Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Constipation Clinical Trial

Official title:

Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807321
• Other study ID #: CALM-CLIN-2023 BFT
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Ataxia
• Constipation
• Dyssynergia

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