Status:
RECRUITING
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Lead Sponsor:
The California Medical Innovations Institute, Inc.
Collaborating Sponsors:
Augusta University Medical Center
Conditions:
Normal Subjects
Fecal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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. Fecobion...
Detailed Description
Defecatory disorders affect 25% of the population and the incidence is rising. These diseases pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and...
Eligibility Criteria
Inclusion
- Subject must provide written informed consent;
- Willing and able to undergo required study tests, surveys, and procedures;
- Age \> 18 years of age.
Exclusion
- Female who is pregnant;
- Prior anorectal surgery;
- Prior bowel resection;
- History of chronic constipation;
- In the opinion of the investigator, the subject is not a suitable candidate for the study.
Key Trial Info
Start Date :
February 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05412069
Start Date
February 15 2023
End Date
March 31 2027
Last Update
October 21 2025
Active Locations (2)
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1
California Medical Innovations Institute
San Diego, California, United States, 92121
2
Augusta University Medical Center
Augusta, Georgia, United States, 30912