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

Not Applicable

Recruiting

• Conditions: Normal Subjects; Fecal Incontinence

• Registration Number: NCT05412069
• Lead Sponsor: The California Medical Innovations Institute, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-5-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subject must provide written informed consent;<br><br> 2. Willing and able to undergo required study tests, surveys, and procedures;<br><br> 3. Age > 18 years of age.<br><br>Exclusion Criteria:<br><br> 1. Female who is pregnant;<br><br> 2. Prior anorectal surgery;<br><br> 3. Prior bowel resection;<br><br> 4. History of chronic constipation;<br><br> 5. In the opinion of the investigator, the subject is not a suitable candidate for the<br> study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length-tension properties of the anal sphincter will be reported;Front-rear pressure difference (in cmH2O) will be measured

Secondary Outcome Measures

Name	Time	Method
Anorectal angle (in degree) will be measured;Expulsion velocity (in mm/s) will be reported