Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549780
• Other study ID #: 18-001427
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Jessica Friton
• Phone: 507-284-0495
• Email: friton.jessica[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Stomal Occlusion Device
Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
William A. Faubion, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire	The patients' overall satisfaction/acceptance with the device: Patient satisfaction/acceptance will be documented on a questionnaire that will be administered to them after the study visit is completed. 10 questions, Likert scale design.	2 hours
Primary	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	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