Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence (NCT05616208) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
United States10 participantsStarted 2022-11-02
Plain-language summary
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females aged 18 years old and over at the time of signing the IRB approved informed consent.
. Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
. In the opinion of the investigator, able to participate in the study.
. Experience four or more FI episodes per 2-week period for the past 12 months. For purposes of this study, FI is defined as the loss of control sufficient to have stool in the subject's undergarments or require the changing of the undergarments. FI does not include the presence of a minimal amount of fecal material on the subject's undergarments and does not require the changing of the undergarments.
. Failed standard medical and surgical therapies for FI as defined below:
. Failure of standard medical therapy is defined as
. Failure of standard surgical therapy is defined as
. Patients with severe passive fecal incontinence are eligible for the trial if they have failed all medical and surgical therapy for fecal incontinence and are being considered for a colostomy.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events of Implanted BioSphincter IAS for patients with severe FI Who Have Failed Standard Treatment
. Symptomatic anorectal disease including hemorrhoid disease, anal fissure, or fistula causing symptoms such as bleeding, swelling, pain, or drainage.
. Pre-existing anorectal pain of any cause.
. Incontinence of flatus only.
. Chronic watery diarrhea unmanaged by medical therapy and which is the primary cause for FI.
. Greater than 60 degrees of either external anal sphincter disruption or both (\>60° IAS and EAS). Patients with severe (\>60 degree) disruption of the EAS ± IAS are likely to have a component of both urge (EAS) and passive (IAS) fecal incontinence. Due to a combined etiology of FI, patients with a large EAS ± IAS disruption are unlikely to have a significant improvement in FI from BioSphincter treatment.
. Acute or chronic anorectal infections (including proctitis, recurrent abscesses, or fistulae).