Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

Study Overview
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Brief Summary
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This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

Detailed Description
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An ostomy is a protrusion of part of the intestines extending through the abdominal wall for the purpose of elimination of wastes and may be temporary or permanent depending on the purpose of the initial surgery. The most common reasons for permanent bowel diversion are cancer and ulcerative colitis. Appliances have improved greatly over the last 50 years, but patients continue to experience appliance leakage and skin infections and struggle with the emotional and social impact of an external pouch. This study seeks to answer the opportunity to significantly improve quality of life to a large segment of the global population through optimization of a technology for a stoma occlusion device in patients with permanent stomas. Four pre-clinical animal studies have been conducted. All the animals that completed the study tolerated the device well and had no adverse reactions to device materials. This project will allow a prototype of an artificial stomal occlusion device to be tested in humans.

Official Title
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A Pilot Study of a Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Stomal Occlusion Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: 18 and older Gender: Male and Female Target disease or condition: 20 patients with permanent End Ileostomy, specifically Brooke ileostomy for greater than 3 years Ability to comply with protocol Competent and able to provide written informed consent Exclusion Criteria: Inability to provide consent Crohn's Disease Koch pouch Pregnancy If subject's stoma length is less than 4 cm or longer than 8 cm Clinically significant medical conditions within the six months before participation with the device that would, in the opinion of the investigators, compromise the safety of the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stomal Occlusion<br>Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction | Device: Stomal Occlusion Device<br>* Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety: Device is able to be inserted adequately (function) and without any significant patient discomfort or adverse events (safety). | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function (continence of device); observed leakage | Device is able to be inserted adequately (function) and without any significant patient discomfort or adverse events (safety). The function (continence) of the stoma occlusion device: After the device has been inserted, a 4 x 4 inch gauze will be placed at the stoma site and secured in place. The gauze functions to document any moisture or leakage of the occlusion device. Consistency and volume of moisture or leakage on the gauze pad will be documented. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brooke Ileostomy, stoma, ileostomy