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

NCT04802538 | Terminated FDA Device

• 1 other identifier: EH19-278
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ileostomy; colostomy; stoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• City of Hope Quality of Life Ostomy Questionnaire Score

  75 days

Study Arms (1)

Study Group

EXPERIMENTAL

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®

Interventions

OstoRing® DEVICE

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Study Officials

• Eugene F Yen, MD, MBA

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Early feasibility device study

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: March 17, 2021
• Study Start: November 6, 2020
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: April 24, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)