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

Part of paid clinical trials in San Diego, California.

Sponsor
The California Medical Innovations Institute, Inc.
Study ID
NCT05412069
Status
Recruiting
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Conditions

  • Fecal Incontinence
  • Normal Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Fecobionics — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 15, 2023
Status verified
Oct 2025
Primary completion
Dec 1, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Fecobionics study
    Fecobionics
  • Active Comparator: Feco BFT
    In this ARM Fecobionics will be used as a BFT tool

Primary Outcome Measure

Length-tension properties of the anal sphincter will be reported [ Time Frame: 1.5 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
California Medical Innovations InstituteSan DiegoCalifornia92121-
Augusta University Medical CenterAugustaGeorgia30912
Satish Rao, MD, PhD
[email protected]
7067212238
Tennekoon Karunaratne, MD, PhD
[email protected]
7067211968

Find similar trials in San Diego, CA

By research site
California Medical Innovations Institute· San Diego, CAAugusta University Medical Center· Augusta, GA

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