Condition: Constipation by Outlet Obstruction · Sponsor: The California Medical Innovations Institute, Inc.
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the …
This description comes directly from the study's public registry record.
Hans Gregersen,, PhD · 858-249-7400 · hag@giome.org
Satish Rao, MD, PhD · 7067212238 · srao@augusta.edu
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| California Medical Innovations Institute | San Diego, California, United States | Active Not Recruiting |
| Augusta University Medical Center | Augusta, Georgia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04903470