Using a new device to improve biofeedback therapy for constipation patients
Official title: Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
Run by The California Medical Innovations Institute, Inc. · NCT05807321 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | The California Medical Innovations Institute, Inc. Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Status | Recruiting |
| Started | October 3, 2023 |
| Main results expected | January 1, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 21, 2025 |
| Trial ID | NCT05807321 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21-75 who have been diagnosed with obstructed defecation or dyssynergia.
✕Probably not a fit
Patients with fecal incontinence, prior anorectal surgery, or severe cardiovascular disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.