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Device

Stomal Occlusion Device for Brooke Ileostomy

N/A
Recruiting
Led By William A Faubion, M.D.
Research Sponsored by William A. Faubion, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

Study Summary

This trial is testing a new device that blocks ileostomies (surgically created holes in the stomach that allow waste to bypass the large intestine). They want to see if it's feasible and has initial operating characteristics. 20 patients will have the device placed in their ileostomy and be observed for 2 hours.

Who is the study for?
This trial is for adults over 18 with a permanent Brooke ileostomy in place for more than 3 years. Candidates should be able to follow the study rules and give informed consent. It's not suitable for individuals with Crohn's Disease, pregnant women, those with stoma lengths outside of 4-8 cm, or anyone unable to consent or with significant medical conditions.Check my eligibility
What is being tested?
The trial is testing a new stomal occlusion device on patients who have had a Brooke ileostomy. The goal is to see how feasible it is and how well it works during a two-hour observation period after placing the device into the ileostomy.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort at the site of insertion, skin irritation around the stoma, or an allergic reaction to materials used in the occlusion device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Function (continence of device); observed leakage
Other outcome measures
Questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stomal OcclusionExperimental Treatment1 Intervention
Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction

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Who is running the clinical trial?

William A. Faubion, M.D.Lead Sponsor
3 Previous Clinical Trials
27 Total Patients Enrolled
William A Faubion, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
7 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being welcomed to participate in this experiment?

"Per information found on clinicaltrials.gov, this trial is currently enrolling patients with the original posting date being August 2nd 2019 and most recent update occurring September 30th 2022."

Answered by AI

What is the aggregate number of subjects enrolled in this clinical trial?

"Affirmative, the information available on clinicaltrials.gov reveals that this research endeavour is presently enlisting participants. This scientific investigation was initially announced on August 2nd 2019 and has been modified most recently on September 30th 2022. 20 individuals from 1 medical centre are required to be recruited for the trial."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
William A. Faubion, M.D. 2019. "Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03549780.
~1 spots leftby Jun 2024
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