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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Hans Gregersen, MD, PhD · PRINCIPAL_INVESTIGATOR · California Medical Innovations Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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