NCT04802538

Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management

A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.

Detailed description

In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Conditions

• Stoma Site Leakage

Interventions

Type	Name	Description
DEVICE	OstoRing®	Participants will use the OstoRing® along with their standard pouching equipment.

Timeline

• Start date: 2020-11-06
• Primary completion: 2021-08-04
• Completion: 2021-08-04
• First posted: 2021-03-17
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study