Evaluating Fecobionics for Fecal Incontinence
A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
This study is testing a new technology called Fecobionics to see how well it can help understand and improve treatment for people with fecal incontinence by mimicking the way normal stool behaves.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The California Medical Innovations Institute, Inc. Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05412069 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the length-tension properties of the anal sphincters using a novel technology called Fecobionics in both normal subjects and patients with fecal incontinence. Fecobionics mimics the consistency and shape of normal stool, allowing for the measurement of pressures, cross-sectional area, and other properties during anal distension and simulated evacuation. By providing multi-dimensional insights into anorectal function, this approach seeks to overcome the limitations of existing diagnostic tests that do not accurately simulate the natural process of defecation. The goal is to improve the understanding and treatment of defecatory disorders, which affect a significant portion of the population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are willing to participate and provide informed consent.
Not a fit: Patients who are pregnant, have had prior anorectal surgery, or have a history of chronic constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostics and treatment options for patients suffering from fecal incontinence and related disorders.
How similar studies have performed: While there is ongoing research in the field of defecatory disorders, the use of Fecobionics represents a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject must provide written informed consent; 2. Willing and able to undergo required study tests, surveys, and procedures; 3. Age \> 18 years of age. Exclusion Criteria: 1. Female who is pregnant; 2. Prior anorectal surgery; 3. Prior bowel resection; 4. History of chronic constipation; 5. In the opinion of the investigator, the subject is not a suitable candidate for the study.
Where this trial is running
San Diego, California and 1 other locations
- California Medical Innovations Institute — San Diego, California, United States (Active_not_recruiting)
- Augusta University Medical Center — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Hans Gregersen, MD, PhD — California Medical Innovations Institute
- Study coordinator: Hans Gregersen, MD, PhD
- Email: hag@giome.org
- Phone: 8582497400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.