OstoRing® for Stoma Leakage (OstoRing Trial)

N/A

Waitlist Available

Led By Eugene F Yen, MD, MBA

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 75 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the OstoRing®, a new ring for ostomy bags, to see if it helps the bags stay on longer and work better. It targets patients who use ostomy equipment to improve their quality of life by making the bags more reliable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 75 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~75 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 75 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Coloplast Tool Skin Assessment Score

Pouching Equipment Wear Time/Lifespan

Secondary study objectives

City of Hope Quality of Life Ostomy Questionnaire Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study GroupExperimental Treatment1 Intervention

All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days.

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Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,639 Total Patients Enrolled

Eugene F Yen, MD, MBA4.324 ReviewsPrincipal Investigator - NorthShore University HealthSystem

NorthShore University HealthSystem

5Patient Review

Dr. Yen is extremely kind and caring. He always puts his patients first and takes the time to listen to their concerns. He is also up-to-date with the latest research.