Trial to Evaluate Fecobionics in Healthy Subjects and Patients (NORMAL)

Neurophysiological Mechanism in Sacral Neuromodulation in Patients Suffering From Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Normal Subjects
• Intervention / Treatment: Device: Fecobionics

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • California Medical Innovations Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecobionics studies; Single-arm study	Device: Fecobionics; Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation
Active Comparator: Feco BFT; In this ARM Fecobionics will be used as a BFT tool	Device: Fecobionics; Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration-based device expulsion parameters	Expulsion Duration - The time it takes to defecate Fecobionics	1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical-based expulsion parameters Endpoints	Mechanical Tension of Fecobionics Device (Pressure multiplied with radius).	1 year
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
Shape-based expulsion parameters	bag shape during defecation. Topographic characteristics of Fecobionics.	1 year

Collaborators and Investigators

• Sponsor: The California Medical Innovations Institute, Inc.
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Hans Gregersen, PhD, California Medical Innovations Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: defecation; anorectal; Fecobionics; bionics
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: CALMI-CLIN-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No