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RECRUITING
NCT05807321
NA

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Sponsor: The California Medical Innovations Institute, Inc.

View on ClinicalTrials.gov

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.

Official title: Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-10-03

Completion Date

2027-03-31

Last Updated

2025-10-21

Healthy Volunteers

No

Interventions

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.

Locations (2)

California Medical Innovations Institute

San Diego, California, United States

Digestive Health Center- Augusta University

Augusta, Georgia, United States