Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

Sponsor

William A. Faubion, M.D. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03549780

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma	Device: Stomal Occlusion Device	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Aug 2, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Stomal Occlusion Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction	Device: Stomal Occlusion Device Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

Arm

Intervention/Treatment

Other: Stomal Occlusion

Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

Device: Stomal Occlusion Device

Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Function (continence of device); observed leakage [2 hours]
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.

Other Outcome Measures

Questionnaire [2 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

William A. Faubion, M.D.

Investigators

Principal Investigator: William A Faubion, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

William A. Faubion, M.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03549780

Other Study ID Numbers:

18-001427

First Posted:

Jun 8, 2018

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by William A. Faubion, M.D., Principal Investigator, Mayo Clinic

Brooke Ileostomy

stoma

ileostomy

Study Results

No Results Posted as of Sep 30, 2021