Constipation Clinical Trial
Official title:
Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
Verified date | December 2023 |
Source | The California Medical Innovations Institute, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | California Medical Innovations Institute | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
The California Medical Innovations Institute, Inc. | Scripps Clinic |
United States,
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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