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Behavioural Intervention

Fecobionics for Bowel Incontinence

N/A
Recruiting
Led By Hans Gregersen, MD, PhD
Research Sponsored by The California Medical Innovations Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 year
Awards & highlights

Study Summary

This trial is designed to study the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics is designed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination.

Who is the study for?
This trial is for individuals aged 18 to 75 who experience bowel incontinence or are healthy volunteers. Participants must be willing and able to complete study procedures and provide consent. It's not suitable for those with chronic constipation, prior bowel resections, anorectal surgery, or pregnant women.Check my eligibility
What is being tested?
The trial tests a device called Fecobionics which mimics natural stool to measure the function of the anal sphincters during defecation. It aims to provide a realistic simulation of bowel movements and gather data on pressure, orientation, and viscoelastic properties of the anorectum.See study design
What are the potential side effects?
As Fecobionics is a diagnostic tool rather than medication, traditional side effects like those seen with drugs may not apply. However, discomfort or potential injury from insertion could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Front-rear pressure difference (in cmH2O) will be measured
Length-tension properties of the anal sphincter will be reported
Secondary outcome measures
Anorectal angle (in degree) will be measured
Expulsion velocity (in mm/s) will be reported

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecobionics studyExperimental Treatment1 Intervention
Fecobionics
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecobionics
2021
N/A
~50

Find a Location

Who is running the clinical trial?

The California Medical Innovations Institute, Inc.Lead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
Augusta University Medical CenterUNKNOWN
1 Previous Clinical Trials
1,456 Total Patients Enrolled
Hans Gregersen, MD, PhDPrincipal InvestigatorCalifornia Medical Innovations Institute

Media Library

Fecobionics (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05412069 — N/A
Bowel Incontinence Research Study Groups: Fecobionics study
Bowel Incontinence Clinical Trial 2023: Fecobionics Highlights & Side Effects. Trial Name: NCT05412069 — N/A
Fecobionics (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412069 — N/A

Frequently Asked Questions

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

Does this clinical trial encompass participants of all ages, including those over 45?

"This trial's eligiblity guidelines include participants ranging from 18 to 75 years old. There are 7 clinical trials available for minors, and 23 other studies suitable for individuals over 65."

Answered by AI

Are any participants still being accepted for this investigation?

"Clinicaltrials.gov indicates that this trial is no longer recruiting, with its initial post date of August 1st 2022 and last update on July 18th 2022. Nevertheless, there are still 30 other studies actively searching for qualified patients to join their clinical trials."

Answered by AI

What types of individuals is this study best suited for?

"This experiment is searching for 30 volunteers aged 18 to 75 with current fecal soiling. These potential participants must provide written consent, demonstrate their willingness and ability to complete the study's tests/surveys/procedures, as well as meet the age requirements of over 18 and under 75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
California
How old are they?
18 - 65
What site did they apply to?
California Medical Innovations Institute
Augusta University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~59 spots leftby Dec 2024