<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/NCT02224859</url>
  </required_header>
  <id_info>
    <org_study_id>INV-CS-001</org_study_id>
    <secondary_id>IND/IDE Number - IRB 013-306</secondary_id>
    <nct_id>NCT02224859</nct_id>
  </id_info>
  <brief_title>Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.</brief_title>
  <acronym>INV-CS-001</acronym>
  <official_title>Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Invictus Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Invictus Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While using the device as a cushion, the passive distribution of pressure over bony skull&#xD;
      prominences of infants will protect against formation of pressure ulcers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD)&#xD;
      when worn by medically stable infants within a neonatal intensive care unit (NICU), to&#xD;
      evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as&#xD;
      well as initial impressions of safety, by health care providers (HCPs) after placing the&#xD;
      current CSD on infants for approximately six (6) hours in a NICU. Specifically, this study&#xD;
      will:&#xD;
&#xD;
        -  Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3&#xD;
           hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments&#xD;
           (temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation,&#xD;
           and adverse events, as reflected in the Table 1.0, Time and Events Table.&#xD;
&#xD;
      Additional safety assessments will be performed following the final removal of the CSD from&#xD;
      the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.&#xD;
&#xD;
        -  Assess the HCP's impression of likely safety and effectiveness (Function Assessments) of&#xD;
           the CSD based on experience working with infants in the NICU, Evaluate/Rate the form and&#xD;
           fit, and evaluate/rate the ease of application of the product.&#xD;
&#xD;
        -  Collect additional feedback (if any) on HCP's impressions of device design and usability&#xD;
           based on experience working as a HCP in the NICU&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Organization has withdrawn their 510k submission and stopped the study&#xD;
  </why_stopped>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.</measure>
    <time_frame>Each patient will spend approximately six (6) hours in the study if no adverse experiences</time_frame>
    <description>Rating scale data will be collected and analyzed using descriptive statistics to determine overall HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device. No hypothesis testing will be conducted. Only descriptive statistics, frequency counts, and proportions will be used to summarize the data. Descriptive statistics, such as number of observations, means, standard deviations, medians, and maximum and minimum values, will be used to summarize the continuous variables. Frequencies and proportions will be used to summarize categorical variables.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Other Preterm Infants</condition>
  <arm_group>
    <arm_group_label>Safety</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Following an initial examination of the scalp and head for baseline evidence of skin integrity (intact, without breaks, lacerations, etc.) and appearance (healthy/normal, no erythema/irritation, etc.) the HCP will place the CSD on the patient and secure the attached Velcro strap to hold the device in place&#xD;
At specific time points (approximately 15 minutes, 1 hour, 3 hours and 6 hours) the HCP (through human intervention)will remove the CSD for examination and completion of the Skin Assessment Scale based on the appearance of the patient's scalp and adjacent areas of the head. Additionally, the patient's head will be observed for excessive scalp sweating/moisture accumulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HCP will place the Invictus Cranial Support Device (CSD) on the patient</intervention_name>
    <description>There is no active therapeutic treatment (e.g., medication, stimulation, etc.) associated with this device or study. All supplies for this study will be supplied by the sponsor and returned to them upon completion of the trial.&#xD;
The device used in this study is a soft gel based bonnet referred to as a Cranial Support Device (CSD). In this study, after obtaining written informed consent from the patient's parent(s) or guardian(s) and confirming that the patient meets all inclusion and no exclusion criteria, the study HCP will place the CSD on the selected patient.</description>
    <arm_group_label>Safety</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>human intervention</intervention_name>
    <description>This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU</description>
    <arm_group_label>Safety</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a parent(s) or guardian(s) who has provided written informed consent for the&#xD;
             patient to participate in the study.&#xD;
&#xD;
          2. Be &gt; 30.0 weeks gestational age at time of enrollment into the study&#xD;
&#xD;
          3. Be in medically stable condition within the NICU&#xD;
&#xD;
          4. Be able to breathe adequately on room air without support&#xD;
&#xD;
          5. Be deemed suitable (i.e., in no acute distress) for participating in the study for&#xD;
             approximately six (6) hours, in the investigator's opinion&#xD;
&#xD;
          6. Upon visual inspection have intact skin without breaks and/or lacerations of the scalp&#xD;
             or adjacent areas where the CSD will fit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is&#xD;
             required,&#xD;
&#xD;
          2. The patient has any genetic dermatological conditions&#xD;
&#xD;
          3. The patient's head size is not appropriate for the device &lt; 28 centimeters or &gt;34.3&#xD;
             centimeters (&lt; 11 or &gt; 13.5 inches)&#xD;
&#xD;
          4. Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.)&#xD;
             that makes participating in the study not in the patient's best interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Weeks</minimum_age>
    <maximum_age>36 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustafa . Suterwala, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>March 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02224859
org study id: INV-CS-001
secondary id: IND/IDE Number - IRB 013-306
nct id: NCT02224859
lead sponsor: 
has dmc: Yes
While using the device as a cushion, the passive distribution of pressure over bony skull
      prominences of infants will protect against formation of pressure ulcers.
This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD)
      when worn by medically stable infants within a neonatal intensive care unit (NICU), to
      evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as
      well as initial impressions of safety, by health care providers (HCPs) after placing the
      current CSD on infants for approximately six (6) hours in a NICU. Specifically, this study
      will:

        -  Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3
           hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments
           (temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation,
           and adverse events, as reflected in the Table 1.0, Time and Events Table.

      Additional safety assessments will be performed following the final removal of the CSD from
      the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.

        -  Assess the HCP's impression of likely safety and effectiveness (Function Assessments) of
           the CSD based on experience working with infants in the NICU, Evaluate/Rate the form and
           fit, and evaluate/rate the ease of application of the product.

        -  Collect additional feedback (if any) on HCP's impressions of device design and usability
           based on experience working as a HCP in the NICU
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.
time frame: Each patient will spend approximately six (6) hours in the study if no adverse experiences
description: Rating scale data will be collected and analyzed using descriptive statistics to determine overall HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device. No hypothesis testing will be conducted. Only descriptive statistics, frequency counts, and proportions will be used to summarize the data. Descriptive statistics, such as number of observations, means, standard deviations, medians, and maximum and minimum values, will be used to summarize the continuous variables. Frequencies and proportions will be used to summarize categorical variables.
arm group label: Safety
arm group type: Other
description: Following an initial examination of the scalp and head for baseline evidence of skin integrity (intact, without breaks, lacerations, etc.) and appearance (healthy/normal, no erythema/irritation, etc.) the HCP will place the CSD on the patient and secure the attached Velcro strap to hold the device in place
At specific time points (approximately 15 minutes, 1 hour, 3 hours and 6 hours) the HCP (through human intervention)will remove the CSD for examination and completion of the Skin Assessment Scale based on the appearance of the patient's scalp and adjacent areas of the head. Additionally, the patient's head will be observed for excessive scalp sweating/moisture accumulation.
intervention type: Device
intervention name: HCP will place the Invictus Cranial Support Device (CSD) on the patient
description: There is no active therapeutic treatment (e.g., medication, stimulation, etc.) associated with this device or study. All supplies for this study will be supplied by the sponsor and returned to them upon completion of the trial.
The device used in this study is a soft gel based bonnet referred to as a Cranial Support Device (CSD). In this study, after obtaining written informed consent from the patient's parent(s) or guardian(s) and confirming that the patient meets all inclusion and no exclusion criteria, the study HCP will place the CSD on the selected patient.
arm group label: Safety
intervention type: Other
intervention name: human intervention
description: This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU
arm group label: Safety
criteria: 
gender: All
minimum age: 30 Weeks
maximum age: 36 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Mustafa . Suterwala, MD
role: Principal Investigator
affiliation: Baylor Health Care System
facility: 
country: United States
responsible party type: Sponsor