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NCT06394115 · ClinicalTrials.gov registry record
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
A clinical trial, sponsored by ConvaTec.
- Completed
- Registry status
- 40
- Enrollment target
NCT06394115: Completed study, sponsored by ConvaTec.
NCT06394115 is a clinical trial that has completed, run by ConvaTec. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06394115 has completed, sponsored by ConvaTec.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
Primary Outcome
To demonstrate the performance of Convatec ostomy pouches which have the novel coating
Interventions
- DEVICE Ostomy pouch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2023-06-19 |
What the finished NCT06394115 record still lists
NCT06394115 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ostomy pouch is the first listed.
NCT06394115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06394115 about?
NCT06394115 is a clinical study titled "Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study". The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be...
What is the current status of trial NCT06394115?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2022-08-01. Estimated completion is 2023-06-19.
What interventions are being tested in trial NCT06394115?
The interventions under investigation include: Ostomy pouch (DEVICE).
Who is sponsoring clinical trial NCT06394115?
This trial is sponsored by ConvaTec, which has 17 total clinical trials registered on ClinicalTrials.gov.
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