NCT05415059

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

June 1, 2022

Last Update Submit

August 5, 2022

Conditions

Adhesion

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 hours

Secondary Outcomes (1)

  • Skin outcomes

    7 days

Study Arms (1)

Main Cohort

OTHER

Cohort of healthy volunteers to have device affixed

Device: Covatech Stoma bag material

Interventions

Covatech Stoma bag materialDEVICE

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

Main Cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 10, 2022

Study Start

August 10, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

For internal use