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

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

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

Study Overview

• Status: Terminated
• Conditions: Stoma Site Leakage
• Intervention / Treatment: Device: OstoRing®

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem Evanston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Are at least 18 years of age and have full legal capacity
• Have had an end or loop ileostomy or colostomy for at least 6 months.
• Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
• Able to provide informed consent
• Have a stoma with a diameter of 57mm or less
• Change their pouching system at least two times in seven days

Exclusion Criteria:

• Unable to give informed consent.
• Are pregnant or currently breastfeeding.
• In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
• In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
• Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
• Currently suffering from a peristomal hernia.
• Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
• In the last 30 days has participated or is currently participating in a clinical study
• Assessed with an ostomy skin tool score of ≥3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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.	Device: OstoRing®; Participants will use the OstoRing® along with their standard pouching equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pouching Equipment Wear Time/Lifespan	Mean pouching system wear time will be calculated with and without the OstoRing®.	75 days
Coloplast Tool Skin Assessment Score	The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area.	75 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
City of Hope Quality of Life Ostomy Questionnaire Score	Quality of life will be assessed at all study visits utilizing the City of Hope Quality of Life Ostomy Questionnaire. This instrument contains 43 questions with answers on a Likert scale from 1 to 10. The final score is the sum of all responses divided by the total number questions which gives a final score from 1 to 10. Greater score on this survey is indicative of a better quality of life.	75 days

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Eugene F Yen, MD, MBA, NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ileostomy; colostomy; stoma
• Other Study ID Numbers: EH19-278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No