NCT04766138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

August 2, 2020

Last Update Submit

October 15, 2025

Conditions

Normal SubjectsFecal Incontinence

Keywords

anorectalFecobionicsdefecationbionics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Mechanical-based expulsion parameters Endpoints

    1 year

  • Device orientation and bending-based expulsion parameters

    1 year

  • Shape-based expulsion parameters

    1 year

Study Arms (2)

Fecobionics studies

EXPERIMENTAL

Single-arm study

Device: Fecobionics

Feco BFT

ACTIVE COMPARATOR

In this ARM Fecobionics will be used as a BFT tool

Device: Fecobionics

Interventions

FecobionicsDEVICE

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

Feco BFTFecobionics studies

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must provide written informed consent;
  • Age 18 years and of age of legal consent;
  • Normal defecation pattern;
  • Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores.

You may not qualify if:

  • Female, who is pregnant or lactating;
  • Prior abdominal surgery;
  • Diagnosis of fecal incontinence, constipation or anorectal pain.
  • For Patients with Fecal Incontinence (in University of California, San Diego):
  • Subject must provide written informed consent;
  • Age 18 years and of age of legal consent;
  • Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment
  • Female, who is pregnant or lactating;
  • Prior abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Medical Innovations Institute

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hans Gregersen, PhD

    California Medical Innovations Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

August 2, 2020

First Posted

February 23, 2021

Study Start

January 1, 2021

Primary Completion

December 9, 2022

Study Completion

March 9, 2023

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)