Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
NCT05807321

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Led by The California Medical Innovations Institute, Inc. · Updated on 2025-10-21

24

Participants Needed

2

Research Sites

182 weeks

Total Duration

On this page

Sponsors

T

The California Medical Innovations Institute, Inc.

Lead Sponsor

S

Scripps Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject must provide written informed consent.
  • Age between 21-75 years.
  • Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the biofeedback therapy at UCSD or Scripps.
Not Eligible

You will not qualify if you...

  • Female who is pregnant or lactating.
  • Prior abdominal or anorectal surgery or bowel resection.
  • Diagnosis of fecal incontinence, any anorectal symptoms, or 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.
  • Other exclusions, at the investigator's discretion, if the volunteer is not suitable for the study.

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

California Medical Innovations Institute

San Diego, California, United States, 92121

Actively Recruiting

2

Digestive Health Center- Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

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Research Team

H

Hans Gregersen, PhD

CONTACT

S

Satish Rao, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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