LEAFix Adhesion in Healthy Volunteers

NCT ID: NCT05415059

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2022-11-30

Brief Summary

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This study compares the adhesiveness of the 3M material to be used in the final design.

Detailed Description

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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.

Conditions

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Adhesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Main Cohort

Cohort of healthy volunteers to have device affixed

Group Type OTHER

Covatech Stoma bag material

Intervention Type DEVICE

Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device

Interventions

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Covatech Stoma bag material

Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SP0935

Identifier Type: -

Identifier Source: org_study_id

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