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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2021-08-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stoma Site Leakage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Early feasibility device study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

OstoRing®

Intervention Type DEVICE

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

Interventions

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OstoRing®

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes