Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
1 other identifier
interventional
155
1 country
2
Brief Summary
The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed 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. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal. The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation (BET and FECOM) and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
October 21, 2025
October 1, 2025
3.8 years
May 31, 2022
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Length-tension properties of the anal sphincter will be reported
1.5 year
Front-rear pressure difference (in cmH2O) will be measured
Fecobionics contain pressure sensors in front end and rear end which can measure pressures
1.5 year
Secondary Outcomes (2)
Anorectal angle (in degree) will be measured
1.5 year
Expulsion velocity (in mm/s) will be reported
1.5 year
Study Arms (2)
Fecobionics study
EXPERIMENTALFecobionics
Feco BFT
ACTIVE COMPARATORIn this ARM Fecobionics will be used as a BFT tool
Interventions
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry, balloon expulsion test, and anal ultrasonography will be used as reference.
Eligibility Criteria
You may qualify if:
- Subject must provide written informed consent;
- Willing and able to undergo required study tests, surveys, and procedures;
- Age \> 18 years of age.
You may not qualify if:
- Female who is pregnant;
- Prior anorectal surgery;
- Prior bowel resection;
- History of chronic constipation;
- In the opinion of the investigator, the subject is not a suitable candidate for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
California Medical Innovations Institute
San Diego, California, 92121, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans Gregersen, MD, PhD
California Medical Innovations Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 9, 2022
Study Start
February 15, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
October 21, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share