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LEAFix Adhesion in Healthy Volunteers

Primary Purpose

Adhesion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Covatech Stoma bag material
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Adhesion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Not been in a trial in last 12 weeks
  • mild to no skin issues

Exclusion Criteria:

  • any significant allergies
  • any allergies to skin adhesive
  • any medium to severe skin issues

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Main Cohort

    Arm Description

    Cohort of healthy volunteers to have device affixed

    Outcomes

    Primary Outcome Measures

    Adhesion after 24 hours
    Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)

    Secondary Outcome Measures

    Skin outcomes
    Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe

    Full Information

    First Posted
    June 1, 2022
    Last Updated
    August 5, 2022
    Sponsor
    Liverpool University Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05415059
    Brief Title
    LEAFix Adhesion in Healthy Volunteers
    Official Title
    Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 10, 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Liverpool University Hospitals NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares the adhesiveness of the 3M material to be used in the final design.
    Detailed Description
    The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal. Participants will also be assessed and followed up for any adverse skin issues.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesion

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Main Cohort
    Arm Type
    Other
    Arm Description
    Cohort of healthy volunteers to have device affixed
    Intervention Type
    Device
    Intervention Name(s)
    Covatech Stoma bag material
    Intervention Description
    Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device
    Primary Outcome Measure Information:
    Title
    Adhesion after 24 hours
    Description
    Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Skin outcomes
    Description
    Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers Not been in a trial in last 12 weeks mild to no skin issues Exclusion Criteria: any significant allergies any allergies to skin adhesive any medium to severe skin issues

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    For internal use

    Learn more about this trial

    LEAFix Adhesion in Healthy Volunteers

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