Trial to Evaluate Fecobionics in Healthy Subjects and Patients

Fecal Incontinence Clinical Trial

— NORMAL  

Official title:

Neurophysiological Mechanism in Sacral Neuromodulation in Patients Suffering From Fecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766138
• Other study ID #: CALMI-CLIN-2019-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: The California Medical Innovations Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 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 healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only.

Description:

Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors. The homeostatic balance is easily disturbed by functional or structural anorectal disturbances that may coexist. Common anorectal disorders are fecal incontinence, functional anorectal pain, and functional defecation disorders. These conditions greatly affect life quality for the patients. Current technologies for anorectal functional assessment studies have limitations and often overlap is found between patient groups with lack of correlation between measurements and symptoms. Defecation physiology has been studied for many years but the mechanics and mechanosensation of defecation are still not well understood.

Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development of Fecobionics was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as close 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 as well as other parameters

The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. Fecobionics exceeds previous attempts to make artificial stool for evaluation of defecation 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 healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only, i.e. studying mechanisms of defecation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 9, 2023
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

For Normal Subjects (in California Medical Innovations Institute):

Inclusion Criteria:

1. Subject must provide written informed consent;

2. Age 18 years and of age of legal consent;

3. Normal defecation pattern;

4. Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores.

Exclusion Criteria:

1. Female, who is pregnant or lactating;

2. Prior abdominal surgery;

3. Diagnosis of fecal incontinence, constipation or anorectal pain.

For Patients with Fecal Incontinence (in University of California, San Diego):

Inclusion Criteria:

1. Subject must provide written informed consent;

2. Age 18 years and of age of legal consent;

3. Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment

Exclusion Criteria:

1. Female, who is pregnant or lactating;

2. Prior abdominal surgery

Related Conditions & MeSH terms

• Fecal Incontinence
• Normal Subjects

Intervention

Device:
• Fecobionics
Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation

Locations

Country	Name	City	State
United States	California Medical Innovations Institute	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
The California Medical Innovations Institute, Inc.	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration-based device expulsion parameters	Expulsion Duration - The time it takes to defecate Fecobionics	1 year
Primary	Pressure-based device expulsion parameters	Pressure difference between front and rear of Fecobionics device - A measure of anal sphincter relaxation and key to the determination of defecation phases. Pressure profiles	1 year
Secondary	Mechanical-based expulsion parameters Endpoints	Mechanical Tension of Fecobionics Device (Pressure multiplied with radius).	1 year
Secondary	Device orientation and bending-based expulsion parameters	orientation of the device (degrees) and bending angle (degrees, a proxy of the anorectal angle during defecation)	1 year
Secondary	Shape-based expulsion parameters	bag shape during defecation. Topographic characteristics of Fecobionics.	1 year