Trial to Evaluate Fecobionics in Healthy Subjects and Patients

NCT ID: NCT04766138

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-03-09

Brief 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.

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.

Conditions

Normal Subjects; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fecobionics studies

Single-arm study

Group Type: EXPERIMENTAL

Fecobionics

Intervention Type: DEVICE

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

Feco BFT

In this ARM Fecobionics will be used as a BFT tool

Group Type: ACTIVE_COMPARATOR

Fecobionics

Intervention Type: DEVICE

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

Interventions

Fecobionics

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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;

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

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

1. Female, who is pregnant or lactating;

2. Prior abdominal surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

The California Medical Innovations Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Hans Gregersen, PhD

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Gregersen, PhD

Role: PRINCIPAL_INVESTIGATOR

California Medical Innovations Institute

Locations

California Medical Innovations Institute

San Diego, California, United States

Countries

United States

Other Identifiers

CALMI-CLIN-2019-01

Identifier Type: -

Identifier Source: org_study_id