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NCT05652010 · ClinicalTrials.gov registry record · NA
Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
A NA study of Surgical Stomas, sponsored by Coloplast A/S.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT05652010: Completed NA study of Surgical Stomas, sponsored by Coloplast A/S.
NCT05652010 is a NA study of Surgical Stomas that has completed, run by Coloplast A/S. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05652010, a NA study of Surgical Stomas, has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
Primary Outcome
Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
Conditions Studied
Interventions
- DEVICE New 2-piece Coupling
- DEVICE SenSura Mio Click
Study Locations (1)
North Carolina
- American Health Research - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2023-07-15 |
| Phase | NA |
What the finished NCT05652010 record still lists
NCT05652010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Surgical Stomas appearing as the primary indexed condition, and to 2 interventions - of which New 2-piece Coupling is the first listed.
NCT05652010 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05652010 about?
NCT05652010 is a clinical study titled "Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma". Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
What is the current status of trial NCT05652010?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2023-02-15. Estimated completion is 2023-07-15.
What conditions does trial NCT05652010 study?
This clinical trial studies the following conditions: Surgical Stomas.
What interventions are being tested in trial NCT05652010?
The interventions under investigation include: New 2-piece Coupling (DEVICE), SenSura Mio Click (DEVICE).
Who is sponsoring clinical trial NCT05652010?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05652010 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05652010's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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