Trial Outcomes & Findings for Clinical Investigation Exploring Two Ostomy Product Prototypes (NCT NCT06237686)

NCT ID: NCT06237686

Last Updated: 2025-06-26

Results Overview

Test product A and B's ability to swell around the stoma (assessed by photo/video)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2025-06-26

Participant Flow

Participant milestones

Measure	One-armed Study CP363: All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	One-armed Study n=10 Participants CP363: All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=10 Participants
Age, Categorical >=65 years	4 Participants n=10 Participants
Age, Continuous	59.1 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment Denmark	10 participants n=10 Participants
Type of stoma Ileostomy	10 Participants n=10 Participants
Type of stoma Other	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: 4 hours

Test product A and B's ability to swell around the stoma (assessed by photo/video)

Outcome measures

Measure	One-armed Study n=10 Participants CP363: All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.
Primary Objective Product A. Completely covered in the swelling area	7 Participants
Primary Objective Product B. Completely covered in the swelling area	4 Participants
Primary Objective Product A. Partly covered in the swelling area	1 Participants
Primary Objective Product B. Partly covered in the swelling area	4 Participants
Primary Objective Product A. Not covered at all in the swelling area	2 Participants
Primary Objective Product B. Not covered at all in the swelling area	2 Participants
Primary Objective Product A. Uniform circular swelling	9 Participants
Primary Objective Product B. Uniform circular swelling	8 Participants
Primary Objective Product A. No uniform circular swelling	1 Participants
Primary Objective Product B. No uniform circular swelling	2 Participants

Adverse Events

One-armed Study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	One-armed Study n=11 participants at risk CP363: All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.
Infections and infestations Viral infection	9.1% 1/11 • Number of events 1 • Each subject was enrolled for 8 days +3 days.

Additional Information

Principal Investigator: Søren Meisner, MD

Medical Consultant

Phone: +4520117378

Email: sm_meisner@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place