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

NCT04802538 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-24

No results posted yet for this study

Summary

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

Conditions

  • Stoma Site Leakage

Interventions

DEVICE

OstoRing®

Participants will use the OstoRing® along with their standard pouching equipment.

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Eugene F Yen, MD, MBA · Endeavor Health

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-08-04
Completion
2021-08-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802538 on ClinicalTrials.gov