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Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)

RecruitingNAAges 18 Years - 75 YearsAllThe California Medical Innovations Institute, Inc.
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In plain words

What the trial is, and whether it could suit you

The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provid

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Fecobionics
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Where

2 sites
California Medical Innovations Institute
San Diego, United States
Augusta University Medical Center
Augusta, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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