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

Launched by THE CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC. · Jun 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called Fecobionics to better understand how the anal sphincters work during bowel movements, particularly in individuals with fecal incontinence (FI) and those without this condition. Fecobionics is designed to mimic the consistency of normal stool and can measure various aspects of the anal area, such as pressure and shape, while a person pretends to have a bowel movement. The goal is to gather detailed information on how the body functions during this natural process to improve our understanding of both healthy and disordered defecation.

To participate in this trial, you need to be over 18 years old and able to give your consent. You should also be willing to take part in the required tests and procedures. However, certain individuals, like pregnant women or those who have had specific surgeries or chronic constipation, may not be eligible. If you join, you'll undergo tests that are designed to be as natural and comfortable as possible, helping researchers gather important insights into bowel function.

Gender

ALL

Eligibility criteria

• 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.