Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.

Study Overview

• Status: Recruiting
• Conditions: Constipation; Dyssynergia
• Intervention / Treatment: Device: Fecobionics

Detailed Description

This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Gregersen, PhD; Phone Number: 858-249-7400; Email: hag@giome.org
• Study Contact Backup: Name: Satish Rao, MD, PhD; Phone Number: 706-7212238; Email: srao@augusta.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • California Medical Innovations Institute
      • Contact: Hans Gregersen, PhD; Phone Number: 858-249-7400; Email: hag@giome.org
      • Contact: Ghassan Kassab, PhD; Phone Number: 858-249-7400; Email: gkassab@calmi2.org
      • Sub-Investigator: Lucy G Barron Del Solar, MD
      • Principal Investigator: Hans Gregersen, MD, PhD
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Digestive Health Center- Augusta University
      • Contact: Satish Rao, MD, Phd; Phone Number: 706-721-2239; Email: srao@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject must provide written informed consent.
2. Age between 21-75 years.
3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.

Exclusion Criteria:

1. Female who is pregnant or lactating.
2. Prior abdominal or anorectal surgery or bowel resection.
3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
4. Confirmed or suspected COVID-19 infection.
5. Severe cardiovascular disease.
6. Subjects not willing to consent and undergo the specified tests in this study.
7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecobionics	Device: Fecobionics; Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.; Other Names: Anorectal manometry; Balloon expulsive test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expulsion Duration	The time it takes to defecate Fecobionics	1.5 year
Pressure Difference between front and rear ends of Fecobionics	A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases.	1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anorectal angle	Anorectal angle is an important parameter for defecation	1.5 year
Mechanical Tension of Fecobionics	To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure.	1.5 year
Expulsion Velocity	Measured from the time difference between multiple sensor data	1.5 year
Cross-sectional area	Computed by diameter	1.5 year

Collaborators and Investigators

• Sponsor: The California Medical Innovations Institute, Inc.
• Collaborators: Scripps Clinic; Augusta University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Fecobionics; Defecation; Biofeedback therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms, Digestive; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Ataxia
• Other Study ID Numbers: CALM-CLIN-2023 BFT

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