Evaluating Fecobionics for Fecal Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Augusta University Medical Center
  Augusta, Georgia, United States Recruiting
• California Medical Innovations Institute
  San Diego, California, United States Active not 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• R20 Sacral Neuromodulation for Fecal Incontinence: Post‑Market Follow‑Up

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• High-intensity electromagnetic stimulation for bowel control after J-pouch surgery

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  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT07034443

• Intra-rectal Botulinum Toxin Injection for Children with Non-Retentive Fecal Incontinence

  This trial tests whether injecting botulinum toxin into the rectum can help children who have frequent non-retentive fecal incontinence that isn’t caused by constipation.

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• Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter

  This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.

  Recruiting Umeå University · Umeå, Västerbotten County · NCT06763861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.