Feasibility of a Newly Developed Ostomy Prototype

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2025-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Stoma - Ileostomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Investigation (one armed study)

Group Type EXPERIMENTAL

CP369 Feasibility of a newly developed ostomy prototype (only one intervention)

Intervention Type DEVICE

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.

Interventions

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CP369 Feasibility of a newly developed ostomy prototype (only one intervention)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No