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CompletedNCT03619226Updated Jul 11, 2025Results posted

Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

An interventional study of test patch in Stoma Ileostomy, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

02

Conditions studied

  • Stoma Ileostomy
03

In context

Lead sponsor

Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Have intact skin on the area used in the evaluation
  4. Have an abdominal area accessible for application of test product (assessed by investigator)
  5. Negative pregnancy test for fertile women
  6. Signed document claiming use of safe contraceptives for fertile women

Exclusion criteria

Exclusion Criteria:

  1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
  2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
  3. Are pregnant or breastfeeding
  4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
  5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    test patch

    two adhesive patches are applied to the abdominal area

    Other: test patch

Interventions

  • Othertest patch

    the test patch consists of an adhesive patch

06

What researchers measure

Primary outcomes

  1. Resistance (Moisture in the Adhesive)

    The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.

    Time frame: 3 days

07

Results

Posted Jul 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneTest Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities
Started6
Completed6
Not completed0

Outcome measures

PrimaryResistance (Moisture in the Adhesive)

The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.

Time frame:
3 days
Reported as:
Number · Number of false positive leaks
Resistance (Moisture in the Adhesive)
Number of false positive leaksTest Patch (Adhesive Patch With Sensor System) + Normal Daily ActivitiesTest Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities
Resistance (Moisture in the Adhesive)00

Adverse events

Collected over 3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities0/6 (0%)0/6 (0%)0/6 (0%)

Baseline characteristics

Healthy volunteers

Age, Continuous
Age, Continuous(years)Test Patch
Mean37 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Test Patch
Female6
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Test Patch
08

Study locations

1 site
  • Coloplast A/S
    Humlebæk, 3050, Denmark
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 23, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03619226
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Aug 7, 2018
Start date
Jul 2, 2018
Primary completion
Jul 4, 2018
Completion
Jul 4, 2018
Results posted
Jul 11, 2025
Last update
Jul 11, 2025

Study contacts

Lene F Nielsen
principal investigator · Head of the pre-clinical department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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