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Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

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ClinicalTrials.gov Identifier: NCT03549780
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
William A. Faubion, M.D., Mayo Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : August 2, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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




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


Secondary Outcome Measures :
  1. Function (continence of device); observed leakage [ Time Frame: 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:
  1. Questionnaire [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549780


Contacts
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Contact: Jessica Friton 507-284-0495 friton.jessica@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jessica Friton    507-284-0495    friton.jessica@mayo.edu   
Sponsors and Collaborators
William A. Faubion, M.D.
Investigators
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Principal Investigator: William A Faubion, M.D. Mayo Clinic

Additional Information:
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Responsible Party: William A. Faubion, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03549780     History of Changes
Other Study ID Numbers: 18-001427
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by William A. Faubion, M.D., Mayo Clinic:
Brooke Ileostomy
stoma
ileostomy