Feasibility of a Newly Developed Ostomy Prototype
1 other identifier
interventional
10
1 country
1
Brief Summary
Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2025
CompletedStudy Start
First participant enrolled
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedAugust 28, 2025
August 1, 2025
1 month
July 25, 2025
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To test the system performance of the prototype.
3 weeks from enrollment to end of treatment
Study Arms (1)
Investigation (one armed study)
EXPERIMENTALInterventions
The study is an open-label, single-arm, comparative study, investigating the feasibility of the prototype in subjects with ileostomy. The study is comparing the prototype exposed only to sweat (abdominal side) with the prototype exposed to sweat and output (peristomal side). Meaning, subjects are their own control.
Eligibility Criteria
You may qualify if:
- Has given written informed consent Is at least 18 years old Has full legal capacity Is able (assessed by the investigator) and willing to adhere to study procedures during study duration.
- Has had an ileostomy for at least 30 days. Has been self-managing their own ostomy product for at least 14 days. Has experienced leakage under the baseplate at least 3 times within the past 2 weeks.
- Is able to fit one of the two test product sizes (Ø50mm or Ø60mm). Uses a flat baseplate Is willing to change their baseplate daily Has intact peristomal skin (assessed by the investigator) Is able to use a smartphone with camera
You may not qualify if:
- Is participating in any other clinical investigation during this investigation Has previously participated or completed this investigation Has a known hypersensitivity towards the prototype used in the investigation Is pregnant Is breast feeding Has more than one ostomy synchronously Has ongoing non-healed abdominal wounds Has planned MR scans during the 24-hour test recording
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast, UserLab
Humlebæk, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2025
First Posted
August 28, 2025
Study Start
August 25, 2025
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
August 28, 2025
Record last verified: 2025-08