A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Subject must provide written informed consent;

• Willing and able to undergo required study tests, surveys, and procedures;

• Age \> 18 years of age.

Locations
United States
California
California Medical Innovations Institute
NOT_YET_RECRUITING
San Diego
Georgia
Augusta University Medical Center
RECRUITING
Augusta
Contact Information
Primary
Hans Gregersen, MD, PhD
hag@giome.org
8582497400
Backup
Satish Rao, MD, PhD
srao@augusta.edu
7067212238
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 155
Treatments
Experimental: Fecobionics study
Fecobionics
Active_comparator: Feco BFT
In this ARM Fecobionics will be used as a BFT tool
Related Therapeutic Areas
Sponsors
Collaborators: Augusta University Medical Center
Leads: The California Medical Innovations Institute, Inc.

This content was sourced from clinicaltrials.gov