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NCT05412069 · ClinicalTrials.gov registry record · NA
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
A NA study of Fecal Incontinence and Normal Subjects, sponsored by The California Medical Innovations Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 2
- Study locations
NCT05412069: Recruiting NA study of Fecal Incontinence and Normal Subjects, sponsored by The California Medical Innovations Institute.
NCT05412069 is a NA study of Fecal Incontinence and Normal Subjects that is actively recruiting participants, run by The California Medical Innovations Institute. The registered enrollment target is 155 participants, below the 328-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412069, a NA study of Fecal Incontinence and Normal Subjects, is actively recruiting participants, sponsored by The California Medical Innovations Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Fecobionics
Study Locations (2)
California
- California Medical Innovations Institute - San Diego
Georgia
- Augusta University Medical Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05412069 shows while recruiting
NCT05412069 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 328-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Fecobionics is the first listed.
NCT05412069 reports a single indexed study location in California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05412069 about?
NCT05412069 is a clinical study titled "Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)". 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, or...
What is the current status of trial NCT05412069?
This trial is currently recruiting. It is a NA study. The enrollment target is 155 participants. The study started on 2023-02-15. Estimated completion is 2027-03-31.
What conditions does trial NCT05412069 study?
This clinical trial studies the following conditions: Fecal Incontinence, Normal Subjects.
What interventions are being tested in trial NCT05412069?
The interventions under investigation include: Fecobionics (DEVICE).
Who is sponsoring clinical trial NCT05412069?
This trial is sponsored by The California Medical Innovations Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05412069 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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