Trials / Completed
CompletedNCT05824351
LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa
Team LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa and Other Low Resource Settings.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tanzanian beeswax-pine resin | Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. |
| DEVICE | Domestic beeswax-pine resin | Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. |
| DEVICE | Hollister's AdaptTM Barrier Rings | Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
Timeline
- Start date
- 2023-06-10
- Primary completion
- 2023-06-23
- Completion
- 2023-06-23
- First posted
- 2023-04-21
- Last updated
- 2024-09-26
- Results posted
- 2024-09-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05824351. Inclusion in this directory is not an endorsement.