Recruiting

Fecobionics

Sponsor:

The California Medical Innovations Institute, Inc.

Code:

NCT05807321

Conditions

Dyssynergia

Constipation

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Fecobionics

Study Details

Brief 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

Dyssynergia

Constipation

Study ID

NCT05807321

Start date

Oct 3, 2023

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject must provide written informed consent.
2. Age between 21-75 years.
3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.

Exclusion Criteria:

1. Female who is pregnant or lactating.
2. Prior abdominal or anorectal surgery or bowel resection.
3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
4. Confirmed or suspected COVID-19 infection.
5. Severe cardiovascular disease.
6. Subjects not willing to consent and undergo the specified tests in this study.
7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Fecobionics

Interventions

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.

Primary outcome measure

  • Expulsion Duration [ Time Frame: 1.5 year ]
  • Pressure Difference between front and rear ends of Fecobionics [ Time Frame: 1.5 year ]

Central Contacts and Locations

Central contacts

Hans Gregersen, PhD

858-249-7400hag@giome.org

Satish Rao, MD, PhD

706-7212238srao@augusta.edu

Locations

California Medical Innovations Institute

Recruiting

San Diego, California, United States, 92121

Contacts

Hans Gregersen, PhD

858-249-7400hag@giome.org

Ghassan Kassab, PhD

858-249-7400gkassab@calmi2.org

Principal Investigator:

Hans Gregersen, MD, PhD

Digestive Health Center- Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Satish Rao, MD, Phd

706-721-2239srao@augusta.edu

More Information

Sponsor

The California Medical Innovations Institute, Inc.

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

  • Fecobionics
  • Biofeedback therapy
  • Defecation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The California Medical Innovations Institute, Inc. on 2025-10-21.