Status:
COMPLETED
Trial to Evaluate Fecobionics in Healthy Subjects and Patients
Lead Sponsor:
The California Medical Innovations Institute, Inc.
Collaborating Sponsors:
University of California, San Diego
Conditions:
Normal Subjects
Fecal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 v...
Detailed Description
Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors....
Eligibility Criteria
Inclusion
- For Normal Subjects (in California Medical Innovations Institute):
- Subject must provide written informed consent;
- Age 18 years and of age of legal consent;
- Normal defecation pattern;
- Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores.
Exclusion
- Female, who is pregnant or lactating;
- Prior abdominal surgery;
- Diagnosis of fecal incontinence, constipation or anorectal pain.
- For Patients with Fecal Incontinence (in University of California, San Diego):
- Inclusion Criteria:
- Subject must provide written informed consent;
- Age 18 years and of age of legal consent;
- Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04766138
Start Date
January 1 2021
End Date
March 9 2023
Last Update
October 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
California Medical Innovations Institute
San Diego, California, United States, 92121