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

Stoma Site Leakage Clinical Trial

— OstoRing  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04802538
• Other study ID #: EH19-278
• Status: Terminated
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: August 4, 2021

Study information

• Verified date: March 2022
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Site Leakage

Intervention

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

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem Evanston Hospital	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pouching Equipment Wear Time/Lifespan	Mean pouching system wear time will be calculated with and without the OstoRing®.	75 days
Primary	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	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