xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998629</url>
    </required_header>
    <id_info>
      <org_study_id>7772</org_study_id>
      <nct_id>NCT05998629</nct_id>
    </id_info>
    <brief_title>Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)</brief_title>
    <official_title>Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Milton S. Hershey Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Milton S. Hershey Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting&#xD;
        approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold&#xD;
        standard for diagnosis of CF but still has a number of limitations. The objectives of this&#xD;
        study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two&#xD;
        synchronous channels as a potential low-cost but potentially accurate test to diagnoses&#xD;
        cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same&#xD;
        system in comparison to the standard clinical laboratory procedures routinely performed in&#xD;
        the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC),&#xD;
        Hershey, PA for assessment of the diagnosis of CF. This is a single institution study&#xD;
        performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or&#xD;
        older capable of providing signed and dated informed consent, 2) subjects with an established&#xD;
        known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and&#xD;
        speak English language. Exclusion criteria include: 1) any medical condition or disorder&#xD;
        known to potentially interfere with accurate measurements of sweat chloride and 2) inability&#xD;
        to understand and speak the English language. Cystic Fibrosis (CF) subjects will be&#xD;
        identified from the population of eligible patients receiving medical care at Penn State&#xD;
        Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be&#xD;
        recruited from various members of the PSH-HMC CF clinical care team, members of the Division&#xD;
        of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and&#xD;
        PSU-University Park research team. The total projected number of combined enrolled subjects&#xD;
        is 30. This is a single day single time study that will require approximately 60 minutes of&#xD;
        subject participation. Potential risks include a) side effects from pilocarpine iontophoresis&#xD;
        sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of&#xD;
        confidentiality. There will be no cost to subjects for study participation. There will be no&#xD;
        reimbursement financially for study participation. There is no benefit to subjects for study&#xD;
        participation. There is the potential benefit to medical science via identification of&#xD;
        improved method to accurately measure sweat chloride for diagnosis of CF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease&#xD;
        affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the&#xD;
        gold standard for diagnosis of CF but still has a number of limitations including 1) common&#xD;
        inability to recover enough sweat volume for test accuracy, termed &quot;quantity not sufficient&quot;&#xD;
        limitation, 2) difficulty of performing in young children and infants, 3) absence of point of&#xD;
        care (POC) simplicity and need to schedule prolonged (&gt; 1 hour) appointment with high&#xD;
        resource and personnel utilization, and 4) still a range of values without one specific&#xD;
        diagnostic cut-off measurement thus creating sweat Cl classifications of negative (normal),&#xD;
        indeterminant, and positive (diagnostic). Multiple publications already exist validating the&#xD;
        use of POC skin-interfaced micro fluidic colorimetric systems in attempts to overcome these&#xD;
        limitations of the still standard of care macroduct sweat collection and analysis system. The&#xD;
        current proposed investigational diagnostic (not therapeutic) device introduces a&#xD;
        skin-interfaced colorimetric bifluidic sweat collection and analyses device with two&#xD;
        synchronous channels to quantify sweat rate and biomarkers (for this study Cl) in real-time,&#xD;
        even during uncertain sweat conditions and activities. This proposed bifluidic system could&#xD;
        provide accurate analysis of biomarkers (including Cl) based upon instantaneous sweat rate.&#xD;
        For consistent of data accrual and analyses in this proposed study, for both methods of sweat&#xD;
        collection pilocarpine iontophoresis will be the method of sweat stimulation. This&#xD;
        skin-interfaced colorimetric bifluidic sweat device with two synchronous channels device is a&#xD;
        closed system design to reduce evaporation and resists contamination from the external&#xD;
        environment. This low-cost yet highly accurate device provides opportunities for clinical&#xD;
        sweat analysis and disease screening in remote and low-resource settings which is currently&#xD;
        non-existent with standard clinical measurements of sweat Cl. In addition, this device can be&#xD;
        easily adapted for other biomarkers, when corresponding colorimetric reagents are exploited.&#xD;
  &#xD;
        Inclusion Criteria: 1) Adults 18 years of age or older capable of providing signed and dated&#xD;
        informed consent, 2) Subjects with an established know diagnosis of cystic fibrosis (CF) or&#xD;
        healthy volunteers, 3) Competent to understand written and spoken English language.&#xD;
  &#xD;
        Exclusion Criteria: Participants receiving medications or with known disorders that can cause&#xD;
        errors in sweat test analysis. Common causes of potential error inducing factors in sweat&#xD;
        test determination include Lithium therapy, mineralocorticoid hormone therapy, adrenal&#xD;
        insufficiency, glycogen storage diseases, hypothyroidism, hypoparathyroidism, nephrogenic&#xD;
        diabetes insipidus, G6PD deficiency, ectodermal dysplasia, or any skin or soft tissue&#xD;
        disorders that could affect obtaining the necessary volume and quality of sweat.&#xD;
        Non-English-speaking subjects will be excluded.&#xD;
  &#xD;
        Study Design: This is a single institution study to be performed entirely at the Penn State&#xD;
        Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA. This is only a single day,&#xD;
        single time study, i.e. VISIT 1 and DAY 1 ONLY. The study involves minimal risk. There is no&#xD;
        anticipated benefit to subjects for study participation. Total subject participation time&#xD;
        will be approximately 60 minutes, after which subjects' participation will end. The total&#xD;
        combined estimated enrollment for both health volunteer subjects and CF subjects will be 30.&#xD;
        Two sweat chloride samples and measurements as per study procedures will be obtained&#xD;
        simultaneously from both arms using pilocarpine iontophoresis.&#xD;
  &#xD;
        Study Procedures: 1) PSH-HMC Clinical Laboratory Department of Pathology SOP dated&#xD;
        14-Nov-2022 &quot;Macroduct Sweat Collection&quot; will be complied for attainment of the sample for&#xD;
        which sweat chloride will be measured at PSH-HMC. The site for this procedure is Suite 520 at&#xD;
        the University Physicians Center, Hershey, PA. After completion of pilocarpine iontophoresis&#xD;
        and following collection of sweat specimens inside the macroduct tubing, the sweat will then&#xD;
        be eluted and analyzed separately. PSH-HMC sample chloride biochemical analyses: a) add&#xD;
        reached 12 μL as indicated in the microfluidic device. The measured color change distance&#xD;
        will be used to determine the chloride concentration according to the linear relationship.2N&#xD;
        nitric acid and s-Diphenylcarbazone, b) rinse with 0.005N mercuric nitrate and titrate to&#xD;
        very light purple color and record volume of mercuric nitrate, c) prepare control standards,&#xD;
        d) calculate the chloride result using the EXCEL calculation template.&#xD;
  &#xD;
        2) PSU-UP sample chloride biochemical analyses: The real-time quantification of sweat rate&#xD;
        and chloride will also be pursued with a skin-interfaced colorimetric microfluidic sweat&#xD;
        device developed at Penn State University- University Park, PA (PSU-UP). In brief, the skin&#xD;
        of the human subjects will first be washed with soap and water and dried with disposable&#xD;
        paper. The device will be attached to the skin near pilocarpine iontophoresis. The experiment&#xD;
        will end after the collected sweat.&#xD;
  &#xD;
        Risks: 1) The attainment of the sweat chloride sample for analyses involves only minimal&#xD;
        risk. Obtaining a sweat chloride sample entails approximately 45-60 minutes for volume&#xD;
        collections plus as per the standard process of pilocarpine iontophoresis (which is the&#xD;
        chemical and electrical process used to stimulate the production of sufficient volumes of&#xD;
        sweat) for approximately 5-10 minutes. CF patients may have had this sweat chloride test&#xD;
        performed at an early age as part of their diagnostic evaluation for CF. During this time&#xD;
        period of collection a electrical charge will be delivered via a battery device to the two&#xD;
        electrodes attached to the skin of both forearms which may cause discomfort such as numbness,&#xD;
        tingling, pins and needles sensation or actual pain, and is expected to resolve with&#xD;
        termination of tests without any expectation of long term sequelae or injury. If such&#xD;
        discomfort becomes excessive or intolerant as per study participant, the process will be&#xD;
        terminated. When the pilocarpine iontophoresis procedure is completed the skin under the gel&#xD;
        pads usually looks red and puffy. Occasionally small whitish blisters can appear. Both&#xD;
        conditions fade quickly and usually disappear without two hours. Very rarely small burns or&#xD;
        blisters can occur. This happens in less than 1 in 50,000 patients. Two samples will be&#xD;
        obtained from separate arms simultaneously at a single timepoint. 2) The recovery of any&#xD;
        private health related information always creates the potential of risk of disclosing this&#xD;
        information beyond the intent of this research study. In accordance with PSH-HMC and Federal&#xD;
        guidelines and policies , all precautions will be taken to avoid this risk including the&#xD;
        &quot;coding&quot; of personal identifiable information and protected health information (including&#xD;
        name, medical record number [if available], age, date of birth, gender, race, medications)&#xD;
        and the security of any information linking this code to personal health and personal&#xD;
        identifiable information being secured in a locked office of Dr. Vender in Biomedical&#xD;
        Research Building (C5860F).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Comparison of sweat chloride measure using standard of care versus experimental device in both control and cystic fibrosis subjects</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sweat chloride concentration using standard of care lab assessment</measure>
      <time_frame>Single point in time measurement 60 minutes after device attachment</time_frame>
      <description>Sweat chloride concentration in mmol/L</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sweat chloride concertation using skin-interfaced colorimetric device</measure>
      <time_frame>Single point in time measurement 60 minutes after device attachment</time_frame>
      <description>Sweat chloride concentration in mmol/L</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cystic Fibrosis</condition>
    <arm_group>
      <arm_group_label>Healthy control subjects experimental device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for healthy control subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy control subjects standard of care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for healthy control subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cystic Fibrosis Subjects experimental device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for cystic fibrosis subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cystic Fibrosis Subjects standard of care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for cystic fibrosis subjects</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels</intervention_name>
      <description>a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels</description>
      <arm_group_label>Cystic Fibrosis Subjects experimental device</arm_group_label>
      <arm_group_label>Healthy control subjects experimental device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of Care laboratory procedure for measurement of sweat</intervention_name>
      <description>a skin-interface sweat measurement using a smart-watch type device</description>
      <arm_group_label>Cystic Fibrosis Subjects standard of care</arm_group_label>
      <arm_group_label>Healthy control subjects standard of care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults 18 years of age or older capable of providing signed and dated informed&#xD;
               consent,&#xD;
  &#xD;
            -  subjects with an established known diagnosis of cystic fibrosis (CF) or healthy&#xD;
               volunteers,&#xD;
  &#xD;
            -  able to understand and speak English language.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any medical condition or disorder known to potentially interfere with accurate&#xD;
               measurements of sweat chloride&#xD;
  &#xD;
            -  inability to understand and speak the English language.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Robert Vender</last_name>
      <phone>17175316525</phone>
      <email>rvender@pennstatehealth.psu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
      <investigator_full_name>Robert Vender</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Sweat Chloride Test</keyword>
    <keyword>Cystic Fibrosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cystic Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998629
  org study id: 7772
  nct id: NCT05998629
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting
        approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold
        standard for diagnosis of CF but still has a number of limitations. The objectives of this
        study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two
        synchronous channels as a potential low-cost but potentially accurate test to diagnoses
        cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same
        system in comparison to the standard clinical laboratory procedures routinely performed in
        the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC),
        Hershey, PA for assessment of the diagnosis of CF. This is a single institution study
        performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or
        older capable of providing signed and dated informed consent, 2) subjects with an established
        known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and
        speak English language. Exclusion criteria include: 1) any medical condition or disorder
        known to potentially interfere with accurate measurements of sweat chloride and 2) inability
        to understand and speak the English language. Cystic Fibrosis (CF) subjects will be
        identified from the population of eligible patients receiving medical care at Penn State
        Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be
        recruited from various members of the PSH-HMC CF clinical care team, members of the Division
        of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and
        PSU-University Park research team. The total projected number of combined enrolled subjects
        is 30. This is a single day single time study that will require approximately 60 minutes of
        subject participation. Potential risks include a) side effects from pilocarpine iontophoresis
        sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of
        confidentiality. There will be no cost to subjects for study participation. There will be no
        reimbursement financially for study participation. There is no benefit to subjects for study
        participation. There is the potential benefit to medical science via identification of
        improved method to accurately measure sweat chloride for diagnosis of CF.
  Background: Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease
        affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the
        gold standard for diagnosis of CF but still has a number of limitations including 1) common
        inability to recover enough sweat volume for test accuracy, termed "quantity not sufficient"
        limitation, 2) difficulty of performing in young children and infants, 3) absence of point of
        care (POC) simplicity and need to schedule prolonged (> 1 hour) appointment with high
        resource and personnel utilization, and 4) still a range of values without one specific
        diagnostic cut-off measurement thus creating sweat Cl classifications of negative (normal),
        indeterminant, and positive (diagnostic). Multiple publications already exist validating the
        use of POC skin-interfaced micro fluidic colorimetric systems in attempts to overcome these
        limitations of the still standard of care macroduct sweat collection and analysis system. The
        current proposed investigational diagnostic (not therapeutic) device introduces a
        skin-interfaced colorimetric bifluidic sweat collection and analyses device with two
        synchronous channels to quantify sweat rate and biomarkers (for this study Cl) in real-time,
        even during uncertain sweat conditions and activities. This proposed bifluidic system could
        provide accurate analysis of biomarkers (including Cl) based upon instantaneous sweat rate.
        For consistent of data accrual and analyses in this proposed study, for both methods of sweat
        collection pilocarpine iontophoresis will be the method of sweat stimulation. This
        skin-interfaced colorimetric bifluidic sweat device with two synchronous channels device is a
        closed system design to reduce evaporation and resists contamination from the external
        environment. This low-cost yet highly accurate device provides opportunities for clinical
        sweat analysis and disease screening in remote and low-resource settings which is currently
        non-existent with standard clinical measurements of sweat Cl. In addition, this device can be
        easily adapted for other biomarkers, when corresponding colorimetric reagents are exploited.
  
        Inclusion Criteria: 1) Adults 18 years of age or older capable of providing signed and dated
        informed consent, 2) Subjects with an established know diagnosis of cystic fibrosis (CF) or
        healthy volunteers, 3) Competent to understand written and spoken English language.
  
        Exclusion Criteria: Participants receiving medications or with known disorders that can cause
        errors in sweat test analysis. Common causes of potential error inducing factors in sweat
        test determination include Lithium therapy, mineralocorticoid hormone therapy, adrenal
        insufficiency, glycogen storage diseases, hypothyroidism, hypoparathyroidism, nephrogenic
        diabetes insipidus, G6PD deficiency, ectodermal dysplasia, or any skin or soft tissue
        disorders that could affect obtaining the necessary volume and quality of sweat.
        Non-English-speaking subjects will be excluded.
  
        Study Design: This is a single institution study to be performed entirely at the Penn State
        Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA. This is only a single day,
        single time study, i.e. VISIT 1 and DAY 1 ONLY. The study involves minimal risk. There is no
        anticipated benefit to subjects for study participation. Total subject participation time
        will be approximately 60 minutes, after which subjects' participation will end. The total
        combined estimated enrollment for both health volunteer subjects and CF subjects will be 30.
        Two sweat chloride samples and measurements as per study procedures will be obtained
        simultaneously from both arms using pilocarpine iontophoresis.
  
        Study Procedures: 1) PSH-HMC Clinical Laboratory Department of Pathology SOP dated
        14-Nov-2022 "Macroduct Sweat Collection" will be complied for attainment of the sample for
        which sweat chloride will be measured at PSH-HMC. The site for this procedure is Suite 520 at
        the University Physicians Center, Hershey, PA. After completion of pilocarpine iontophoresis
        and following collection of sweat specimens inside the macroduct tubing, the sweat will then
        be eluted and analyzed separately. PSH-HMC sample chloride biochemical analyses: a) add
        reached 12 μL as indicated in the microfluidic device. The measured color change distance
        will be used to determine the chloride concentration according to the linear relationship.2N
        nitric acid and s-Diphenylcarbazone, b) rinse with 0.005N mercuric nitrate and titrate to
        very light purple color and record volume of mercuric nitrate, c) prepare control standards,
        d) calculate the chloride result using the EXCEL calculation template.
  
        2) PSU-UP sample chloride biochemical analyses: The real-time quantification of sweat rate
        and chloride will also be pursued with a skin-interfaced colorimetric microfluidic sweat
        device developed at Penn State University- University Park, PA (PSU-UP). In brief, the skin
        of the human subjects will first be washed with soap and water and dried with disposable
        paper. The device will be attached to the skin near pilocarpine iontophoresis. The experiment
        will end after the collected sweat.
  
        Risks: 1) The attainment of the sweat chloride sample for analyses involves only minimal
        risk. Obtaining a sweat chloride sample entails approximately 45-60 minutes for volume
        collections plus as per the standard process of pilocarpine iontophoresis (which is the
        chemical and electrical process used to stimulate the production of sufficient volumes of
        sweat) for approximately 5-10 minutes. CF patients may have had this sweat chloride test
        performed at an early age as part of their diagnostic evaluation for CF. During this time
        period of collection a electrical charge will be delivered via a battery device to the two
        electrodes attached to the skin of both forearms which may cause discomfort such as numbness,
        tingling, pins and needles sensation or actual pain, and is expected to resolve with
        termination of tests without any expectation of long term sequelae or injury. If such
        discomfort becomes excessive or intolerant as per study participant, the process will be
        terminated. When the pilocarpine iontophoresis procedure is completed the skin under the gel
        pads usually looks red and puffy. Occasionally small whitish blisters can appear. Both
        conditions fade quickly and usually disappear without two hours. Very rarely small burns or
        blisters can occur. This happens in less than 1 in 50,000 patients. Two samples will be
        obtained from separate arms simultaneously at a single timepoint. 2) The recovery of any
        private health related information always creates the potential of risk of disclosing this
        information beyond the intent of this research study. In accordance with PSH-HMC and Federal
        guidelines and policies , all precautions will be taken to avoid this risk including the
        "coding" of personal identifiable information and protected health information (including
        name, medical record number [if available], age, date of birth, gender, race, medications)
        and the security of any information linking this code to personal health and personal
        identifiable information being secured in a locked office of Dr. Vender in Biomedical
        Research Building (C5860F).
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Comparison of sweat chloride measure using standard of care versus experimental device in both control and cystic fibrosis subjects
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sweat chloride concentration using standard of care lab assessment
  time frame: Single point in time measurement 60 minutes after device attachment
  description: Sweat chloride concentration in mmol/L
  measure: Sweat chloride concertation using skin-interfaced colorimetric device
  time frame: Single point in time measurement 60 minutes after device attachment
  description: Sweat chloride concentration in mmol/L
  arm group label: Healthy control subjects experimental device
  arm group type: Experimental
  description: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for healthy control subjects
  arm group label: Healthy control subjects standard of care
  arm group type: Active Comparator
  description: standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for healthy control subjects
  arm group label: Cystic Fibrosis Subjects experimental device
  arm group type: Experimental
  description: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for cystic fibrosis subjects
  arm group label: Cystic Fibrosis Subjects standard of care
  arm group type: Active Comparator
  description: standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for cystic fibrosis subjects
  intervention type: Device
  intervention name: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels
  description: a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels
  arm group label: Cystic Fibrosis Subjects experimental device
  arm group label: Healthy control subjects experimental device
  intervention type: Other
  intervention name: Standard of Care laboratory procedure for measurement of sweat
  description: a skin-interface sweat measurement using a smart-watch type device
  arm group label: Cystic Fibrosis Subjects standard of care
  arm group label: Healthy control subjects standard of care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Vender
  phone: 17175316525
  email: rvender@pennstatehealth.psu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Milton S. Hershey Medical Center
  investigator full name: Robert Vender
  investigator title: Principal Investigator
  mesh term: Cystic Fibrosis
  mesh term: Fibrosis
  sharing ipd: No