Using a new device to improve biofeedback therapy for constipation patients
Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
This study is testing a new device to see if it can help doctors figure out which constipation patients will benefit from biofeedback therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | The California Medical Innovations Institute, Inc. Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05807321 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a novel device called Fecobionics to assess anorectal function in patients with pelvic floor dyssynergia, a condition that contributes to constipation. The device records physiological parameters during defecation and helps monitor the effectiveness of biofeedback therapy. Participants will perform various motions while the device is inserted, allowing researchers to gather detailed data that may predict treatment outcomes. The goal is to identify which patients are likely to benefit from biofeedback therapy before treatment begins.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-75 who have been diagnosed with obstructed defecation or dyssynergia.
Not a fit: Patients with fecal incontinence, prior anorectal surgery, or severe cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatments for patients suffering from constipation due to dyssynergia.
How similar studies have performed: While the use of biofeedback therapy is established, the specific application of Fecobionics for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California and 1 other locations
- California Medical Innovations Institute — San Diego, California, United States (Recruiting)
- Digestive Health Center- Augusta University — Augusta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Hans Gregersen, PhD
- Email: hag@giome.org
- Phone: 858-249-7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.