An interventional study of Fecobionics in Dyssynergia and Constipation, sponsored by The California Medical Innovations Institute, Inc.. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by The California Medical Innovations Institute, Inc. · Not applicable, Interventional, and Basic science
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.
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.
149 studies on the registry are indexed under Ataxia; 37 are open to participants now.
This study's planned enrollment of 24 is below the median of 30 across 100 interventional studies indexed under Ataxia.
Browse Ataxia studies →The California Medical Innovations Institute, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Anorectal manometry, Balloon expulsive test
Expulsion Duration
The time it takes to defecate Fecobionics
Time frame: 1.5 year
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.
Time frame: 1.5 year
Anorectal angle
Anorectal angle is an important parameter for defecation
Time frame: 1.5 year
Mechanical Tension of Fecobionics
To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure.
Time frame: 1.5 year
Expulsion Velocity
Measured from the time difference between multiple sensor data
Time frame: 1.5 year
Cross-sectional area
Computed by diameter
Time frame: 1.5 year
Started Oct 2023 (actual). Primary completion is estimated for Jan 2027, 38 months after the start.
Of 53 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 38 months is above that.
Counting every sponsor, half of 55 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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The California Medical Innovations Institute, Inc.