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/NCT05975632</url>
    </required_header>
    <id_info>
      <org_study_id>CR-2023-001</org_study_id>
      <nct_id>NCT05975632</nct_id>
    </id_info>
    <brief_title>GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.</brief_title>
    <official_title>GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CardioRenal</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CardioRenal</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>
        Multicentre, open, prospective and interventional study investigating the CardioRenal device&#xD;
        in capillary blood of patients.It will be conducted at multiple investigational sites.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives are to assess the quantitative accuracy in freshly collected whole capillary blood&#xD;
        from patients and healthy volunteers and to evaluate user proficiency. In order to gather a&#xD;
        wide range of K+ concentrations, the study will be conducted both on patients or healthy&#xD;
        volunteers and on dialysis patients.&#xD;
  &#xD;
        The study includes 2 phases (calibration phase and comparison phase) where blood samples&#xD;
        (capillary and venous) will be collected.Blood is taken from the subject by trained&#xD;
        specialist staff. During the comparison phase, the subjects will be equipped with CardioRenal&#xD;
        device and trained to do the self-test.&#xD;
  &#xD;
        A subject's participation in this study (both calibration and validation phase) will consist&#xD;
        of two interventional visits for hemodialysis patients and three interventional visits for&#xD;
        other subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Calibrations factors and correlations R²</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
      <description>potassium values</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry)</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
      <description>potassium values</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determination of mean, standard deviation (SD) and coefficient of variation (CV)</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
      <description>repeatability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability Evaluation questionnaire</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Record and evaluate adverse events</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Potassium Measurement</condition>
    <arm_group>
      <arm_group_label>Potassium measurement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Calibration Phase : 1 visit (duration 1 day) for subjects not on dialysis and hemodialysis patients Comparaison Phase : 1 visit (diration 1 day) for hemodialysis patients Comparaison Phase : 2 visits (diration 1 day) for subjects not on dialysis</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Device: Self testing Potassium device</intervention_name>
      <description>Calibration Phase (1 visit) (Hemodialysis patients and subjects not on dialysis) Each patient will have one venous blood collection. Among them, one 30 patients one capillary sample is collected. In this phase, the HCP is the user of the device.&#xD;
  Comparison Phase&#xD;
  For subject not on dialysis (total 2 visits):&#xD;
  Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test&#xD;
  For Hemodialysis patients (total 1 visit) :&#xD;
  Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test</description>
      <arm_group_label>Potassium measurement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for subjects not on dialysis:&#xD;
  &#xD;
            -  Male/female subject, aged 18+ years ;&#xD;
  &#xD;
            -  Signing a written informed consent ;&#xD;
  &#xD;
            -  Willing to perform the self-test after viewing the instruction for use;&#xD;
  &#xD;
            -  Covered by Health Insurance System and / or in compliance with the recommendations of&#xD;
               National Law in force relating to biomedical research.&#xD;
  &#xD;
          Inclusion Criteria for hemodialysis patients:&#xD;
  &#xD;
            -  Male/female subject, aged 18+ years ;&#xD;
  &#xD;
            -  Medical history of hyperkalemia ;&#xD;
  &#xD;
            -  Signing a written informed consent ;&#xD;
  &#xD;
            -  Willing to perform the self-test after viewing the instruction for use;&#xD;
  &#xD;
            -  Covered by Health Insurance System and / or in compliance with the recommendations of&#xD;
               National Law in force relating to biomedical research.&#xD;
  &#xD;
          Non-inclusion Criteria for subjects not on dialysis:&#xD;
  &#xD;
            -  Medical history of seizure (epilepsy)&#xD;
  &#xD;
            -  Known inherited hemolytic anemia&#xD;
  &#xD;
            -  Autoimmune hemolytic anemia&#xD;
  &#xD;
            -  Infectious Hemolytic anemia&#xD;
  &#xD;
            -  Prosthetic Cardiac valves&#xD;
  &#xD;
            -  Hemolytic uremic syndrome&#xD;
  &#xD;
            -  Peripheral edema&#xD;
  &#xD;
            -  Dehydration&#xD;
  &#xD;
            -  Peripheral Arterial Obstructive Disease (PAOD)&#xD;
  &#xD;
            -  Raynaud syndrome&#xD;
  &#xD;
            -  Known evolutive cancers&#xD;
  &#xD;
            -  Subjects who are pregnant or breast-feeding&#xD;
  &#xD;
            -  Vulnerable patients, patients deprived from liberty and patients with a physical or&#xD;
               mental state altered by disease, age or disability which impacts their ability to&#xD;
               defend their interests and for which protection measures are taken&#xD;
  &#xD;
            -  Subject who, in the judgment of the Investigator, is likely to be non-compliant or&#xD;
               uncooperative during the study, or unable to cooperate because of a language problem,&#xD;
               poor mental development&#xD;
  &#xD;
            -  Subject who is prohibited from participation in the study after consulting the&#xD;
               Ministry of Health National File (e.g. indemnities &gt; 6000 euros for a 12-months&#xD;
               period)&#xD;
  &#xD;
          Non-inclusion Criteria for hemodialysis patients:&#xD;
  &#xD;
            -  Medical history of seizure (epilepsy)&#xD;
  &#xD;
            -  Known inherited hemolytic anemia&#xD;
  &#xD;
            -  Autoimmune hemolytic anemia&#xD;
  &#xD;
            -  Infectious Hemolytic anemia&#xD;
  &#xD;
            -  Prosthetic Cardiac valves&#xD;
  &#xD;
            -  Hemolytic uremic syndrome&#xD;
  &#xD;
            -  Peripheral edema&#xD;
  &#xD;
            -  Dehydration&#xD;
  &#xD;
            -  Peripheral Arterial Obstructive Disease (PAOD)&#xD;
  &#xD;
            -  Raynaud syndrome&#xD;
  &#xD;
            -  Known evolutive cancers&#xD;
  &#xD;
            -  Subjects who are pregnant or breast-feeding&#xD;
  &#xD;
            -  Vulnerable patients, patients deprived from liberty and patients with a physical or&#xD;
               mental state altered by disease, age or disability which impacts their ability to&#xD;
               defend their interests and for which protection measures are taken&#xD;
  &#xD;
            -  Subject who, in the judgment of the Investigator, is likely to be non-compliant or&#xD;
               uncooperative during the study, or unable to cooperate because of a language problem,&#xD;
               poor mental development&#xD;
  &#xD;
            -  Subject who is prohibited from participation in the study after consulting the&#xD;
               Ministry of Health National File (e.g. indemnities &gt; 6000 euros for a 12-months&#xD;
               period)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Philippe ZAOUI</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Grenoble-Alpes Service de Nephrologie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maurice BERENGER, PhD</last_name>
      <phone>+33613903869</phone>
      <email>support@cardio-renal.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre d'Investigation Clinique</name>
        <address>
          <city>Grenoble</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>CHU Grenoble-Alpes</name>
        <address>
          <city>Grenoble</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Philippe Zaoui</last_name>
        <email>PZaoui@chu-grenoble.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Agduc La Tronche</name>
        <address>
          <city>La Tronche</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Philippe Zaoui</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Biogroup</name>
        <address>
          <city>Meylan</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>self-test</keyword>
    <keyword>capillary collection</keyword>
    <keyword>in-vitro diagnostic medical device</keyword>
    <!-- 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/NCT05975632
  org study id: CR-2023-001
  nct id: NCT05975632
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Multicentre, open, prospective and interventional study investigating the CardioRenal device
        in capillary blood of patients.It will be conducted at multiple investigational sites.
  Objectives are to assess the quantitative accuracy in freshly collected whole capillary blood
        from patients and healthy volunteers and to evaluate user proficiency. In order to gather a
        wide range of K+ concentrations, the study will be conducted both on patients or healthy
        volunteers and on dialysis patients.
  
        The study includes 2 phases (calibration phase and comparison phase) where blood samples
        (capillary and venous) will be collected.Blood is taken from the subject by trained
        specialist staff. During the comparison phase, the subjects will be equipped with CardioRenal
        device and trained to do the self-test.
  
        A subject's participation in this study (both calibration and validation phase) will consist
        of two interventional visits for hemodialysis patients and three interventional visits for
        other subjects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Calibrations factors and correlations R²
  time frame: through study completion, an average of 3 months
  description: potassium values
  measure: Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry)
  time frame: through study completion, an average of 3 months
  description: potassium values
  measure: Determination of mean, standard deviation (SD) and coefficient of variation (CV)
  time frame: through study completion, an average of 3 months
  description: repeatability
  measure: Usability Evaluation questionnaire
  time frame: through study completion, an average of 3 months
  measure: Record and evaluate adverse events
  time frame: through study completion, an average of 3 months
  arm group label: Potassium measurement
  arm group type: Experimental
  description: Calibration Phase : 1 visit (duration 1 day) for subjects not on dialysis and hemodialysis patients Comparaison Phase : 1 visit (diration 1 day) for hemodialysis patients Comparaison Phase : 2 visits (diration 1 day) for subjects not on dialysis
  intervention type: Device
  intervention name: Device: Self testing Potassium device
  description: Calibration Phase (1 visit) (Hemodialysis patients and subjects not on dialysis) Each patient will have one venous blood collection. Among them, one 30 patients one capillary sample is collected. In this phase, the HCP is the user of the device.
  Comparison Phase
  For subject not on dialysis (total 2 visits):
  Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test
  For Hemodialysis patients (total 1 visit) :
  Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test
  arm group label: Potassium measurement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Philippe ZAOUI
  role: Principal Investigator
  affiliation: CHU Grenoble-Alpes Service de Nephrologie
  last name: Maurice BERENGER, PhD
  phone: +33613903869
  email: support@cardio-renal.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  country: France
  responsible party type: Sponsor