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NCT05224544 · ClinicalTrials.gov registry record · NA
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
A NA study, sponsored by Coloplast A/S.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT05224544: Completed NA study, sponsored by Coloplast A/S.
NCT05224544 is a NA study that has completed, run by Coloplast A/S. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05224544, a NA study, has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
Primary Outcome
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
Interventions
- DEVICE Investigational prototype device
- DEVICE Comparator device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2022-03-31 |
| Phase | NA |
What the finished NCT05224544 record still lists
NCT05224544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Investigational prototype device is the first listed.
NCT05224544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05224544 about?
NCT05224544 is a clinical study titled "Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter". This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which l...
What is the current status of trial NCT05224544?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2022-01-31. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT05224544?
The interventions under investigation include: Investigational prototype device (DEVICE), Comparator device (DEVICE).
Who is sponsoring clinical trial NCT05224544?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05224544's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 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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