Fecobionics in Biofeedback Therapy in Dyssynergia Patients

NCT05807321 | Recruiting DMC

• 1 other identifier: CALM-CLIN-2023 BFT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dyssynergia; Constipation

Keywords

Fecobionics; Biofeedback therapy; Defecation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Anorectal angle

  1.5 year

• Mechanical Tension of Fecobionics

  1.5 year

• Expulsion Velocity

  1.5 year

• Cross-sectional area

  1.5 year

Study Arms (1)

Fecobionics

EXPERIMENTAL

Device: Fecobionics

Interventions

Fecobionics DEVICE

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.

Also known as: Anorectal manometry, Balloon expulsive test

Fecobionics

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Female who is pregnant or lactating.
• Prior abdominal or anorectal surgery or bowel resection.
• Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
• Confirmed or suspected COVID-19 infection.
• Severe cardiovascular disease.
• Subjects not willing to consent and undergo the specified tests in this study.

Sponsors & Collaborators

• The California Medical Innovations Institute, Inc.: lead
• Scripps Clinic: collaborator
• Augusta University Medical Center: collaborator

Study Sites (2)

California Medical Innovations Institute

San Diego, California, 92121, United States

RECRUITING

Digestive Health Center- Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Ataxia; Constipation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Hans Gregersen, PhD

CONTACT

858-249-7400; hag@giome.org

Satish Rao, MD, PhD

CONTACT

706-7212238; srao@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 11, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (2)