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Fecobionics in Biofeedback Therapy in Dyssynergia Patients

NCT05807321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Scripps Clinic

    collaborator OTHER

  • Augusta University Medical Center

    collaborator UNKNOWN

  • The California Medical Innovations Institute, Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2027-01-01
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807321 on ClinicalTrials.gov