NCT05807321 Fecobionics in Biofeedback Therapy in Dyssynergia Patients
| NCT ID | NCT05807321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The California Medical Innovations Institute, Inc. |
| Condition | Dyssynergia |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-10-03 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-10-03 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05807321 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Dyssynergia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807321 currently recruiting?
Yes, NCT05807321 is actively recruiting participants. Contact the research team at hag@giome.org for enrollment information.
Where is the NCT05807321 trial being conducted?
This trial is being conducted at San Diego, United States, Augusta, United States.
Who is sponsoring the NCT05807321 clinical trial?
NCT05807321 is sponsored by The California Medical Innovations Institute, Inc.. The trial plans to enroll 24 participants.