Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

NCT03549780 | Completed FDA Device

• 1 other identifier: 18-001427
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma

Keywords

Brooke Ileostomy; stoma; ileostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Function (continence of device); observed leakage

  2 hours

Other Outcomes (1)

• Questionnaire

  2 hours

Study Arms (1)

Stomal Occlusion

OTHER

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

Device: Stomal Occlusion Device

Interventions

Stomal Occlusion Device DEVICE

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

Stomal Occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William A. Faubion, M.D.: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• William A Faubion, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 8, 2018
• Study Start: August 2, 2019
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)