Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Part of paid clinical trials in San Diego, California.

Sponsor
The California Medical Innovations Institute, Inc.
Study ID
NCT05807321
Status
Recruiting
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Conditions

  • Constipation
  • Dyssynergia

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 3, 2023
Status verified
Oct 2025
Primary completion
Jan 1, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Fecobionics

Primary Outcome Measure

Expulsion Duration [ Time Frame: 1.5 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
California Medical Innovations InstituteSan DiegoCalifornia92121
Hans Gregersen, PhD
[email protected]
858-249-7400
Ghassan Kassab, PhD
[email protected]
858-249-7400
Lucy G Barron Del Solar, MD (SUB_INVESTIGATOR)
Hans Gregersen, MD, PhD (PRINCIPAL_INVESTIGATOR)
Digestive Health Center- Augusta UniversityAugustaGeorgia30912
Satish Rao, MD, Phd
[email protected]
706-721-2239

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