Actively Recruiting
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
Eligibility Criteria
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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