Trial to Evaluate Fecobionics in Fecal Incontinence

This study is testing a new device called Fecobionics. It's designed to be inserted into the rectum through the anal canal to better understand how the body works during defecation (having a bowel movement). Fecobionics is shaped like normal stool and can measure pressures and other details about your anorectum (the area including the anus and rectum). The goal is to understand the strength and flexibility of the anal sphincter (the muscle that controls bowel movements) in people with normal bowel function and those with fecal incontinence (accidental bowel leakage). You might be able to join if you are between 18 and 75 years old, are not pregnant, and haven't had certain prior surgeries or chronic constipation. The study aims to measure anal sphincter properties and pressure differences over 1.5 years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 155 participants, including both healthy individuals and those with fecal incontinence.
What's involved
You would need to provide written consent and be willing and able to undergo required study tests, surveys, and procedures.
Compensation
Not stated in the trial record.
Follow-up
Measurements for the main goals of the study will be taken at 1.5 years.

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NCT05412069

Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)

Recruiting
NAAges 18–75InterventionalBasic science
The California Medical Innovations Institute, Inc.
~155 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Fecobionics

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Length-tension properties of the anal sphincter will be reported
Measured over 1.5 year
+1 more outcome measured
Normal Subjects
Fecal Incontinence
2 sites across 2 states
California1
Georgia1
  • Hans Gregersen, MD, PhD · PRINCIPAL_INVESTIGATOR · California Medical Innovations Institute

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  • Length-tension properties of the anal sphincter will be reported1.5 year
  • Front-rear pressure difference (in cmH2O) will be measured1.5 year

    Fecobionics contain pressure sensors in front end and rear end which can measure pressures