Rochester, Minnesota 55905

  • Stoma

Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

18-001427


NCT ID:

NCT03549780


Secondary ID:


Study Acronym:


Brief Title:

Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William A Faubion, M.D.
Principal Investigator
Mayo Clinic
Primary Contact:Jessica Friton
507-284-0495
friton.jessica@mayo.edu

Study Dates

Start Date:August 2, 2019
Completion Date:August 2022
Completion Type:Anticipated
Primary Completion Date:August 2021
Primary Completion Type:Anticipated
Verification Date:September 2020
Last Changed Date:September 28, 2020
First Received Date:May 16, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Function (continence of device); observed leakage
Time Frame:2 hours
Safety Issues:False
Description: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 a
Outcome Type:Primary Outcome
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:2 hours
Safety Issues:False
Description:Safety: Device is able to be inserted adequately (function) and without any significant patient discomfort or adverse events (safety).

Study Interventions

Intervention Type:Device
Name:Stomal Occlusion Device
Description:Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction
Arm Name:Stomal Occlusion

Study Arms

Study Arm Type:Other
Arm Name:Stomal Occlusion
Description:Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:William A. Faubion, M.D.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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