Trials / Completed
CompletedNCT06394115
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ostomy pouch | Ostomy pouch coated with novel technology |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-03-30
- Completion
- 2023-06-19
- First posted
- 2024-05-01
- Last updated
- 2024-05-01
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06394115. Inclusion in this directory is not an endorsement.