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 range18 Years
SexALL
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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
✕. 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.
✕
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
✕. 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).