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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05807321
Other study ID # CALM-CLIN-2023 BFT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date March 31, 2025

Study information

Verified date December 2023
Source The California Medical Innovations Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.


Description:

This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date March 31, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subject must provide written informed consent. 2. Age between 21-75 years. 3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps. Exclusion Criteria: 1. Female who is pregnant or lactating. 2. Prior abdominal or anorectal surgery or bowel resection. 3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function. 4. Confirmed or suspected COVID-19 infection. 5. Severe cardiovascular disease. 6. Subjects not willing to consent and undergo the specified tests in this study. 7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fecobionics
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.

Locations

Country Name City State
United States California Medical Innovations Institute San Diego California

Sponsors (2)

Lead Sponsor Collaborator
The California Medical Innovations Institute, Inc. Scripps Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expulsion Duration The time it takes to defecate Fecobionics 1.5 year
Primary Pressure Difference between front and rear ends of Fecobionics A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases. 1.5 year
Secondary Anorectal angle Anorectal angle is an important parameter for defecation 1.5 year
Secondary Mechanical Tension of Fecobionics To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure. 1.5 year
Secondary Expulsion Velocity Measured from the time difference between multiple sensor data 1.5 year
Secondary Cross-sectional area Computed by diameter 1.5 year
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