DyssynergiaNCT05807321
Fecobionics in Biofeedback Therapy in Dyssynergia Patients
A study testing Fecobionics in people with Dyssynergia and Constipation, run by The California Medical Innovations Institute, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Dyssynergia, Constipation
- What is being tested?
- Fecobionics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent.
- Age between 21-75 years.
- Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
Who cannot join
- Female who is pregnant or lactating.
- Prior abdominal or anorectal surgery or bowel resection.
- Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
- Confirmed or suspected COVID-19 infection.
- Severe cardiovascular disease.
- Subjects not willing to consent and undergo the specified tests in this study.
- Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Digestive Health Center- Augusta University
Augusta, Georgia, 30912
Satish Rao, MD, Phd, 706-721-2239, srao@augusta.edu
- Recruiting
California Medical Innovations Institute
San Diego, California, 92121
Hans Gregersen, PhD, 858-249-7400, hag@giome.org
Ghassan Kassab, PhD, 858-249-7400, gkassab@calmi2.org
About this study
Official title: Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
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.
Read the detailed description
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.
- Conditions
- Dyssynergia, Constipation
- Being tested
- Fecobionics
- Keywords
- Fecobionics, Biofeedback therapy, Defecation
- Medical subject headings
- Ataxia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FecobionicsDevice
Also called Anorectal manometry, Balloon expulsive test
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.
| Study group | Role | What they receive |
|---|---|---|
| Fecobionics | Experimental | Not described Receives: Device: Fecobionics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion Duration
The time it takes to defecate Fecobionics
Measured: 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.
Measured: 1.5 year
Secondary outcomes (4)
Anorectal angle
Anorectal angle is an important parameter for defecation
Measured: 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.
Measured: 1.5 year
Expulsion Velocity
Measured from the time difference between multiple sensor data
Measured: 1.5 year
Cross-sectional area
Computed by diameter
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start3 Oct 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyssynergiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The California Medical Innovations Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Scripps Clinic, Augusta University Medical Center
- Responsible party
- Principal investigator, Hans Gregersen, PhD, The California Medical Innovations Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807321
- Sponsor's protocol ID
- CALM-CLIN-2023 BFT
- Status last verified
- Oct 2025
- First submitted
- 16 Mar 2023
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
- ClinicalTrials.gov ID
- NCT05807321
- Acronym / sponsor ID
- CALM-CLIN-2023 BFT
- Conditions
- Dyssynergia, Constipation
- Keywords
- Fecobionics, Biofeedback therapy, Defecation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The California Medical Innovations Institute, Inc.University, hospital or other
- Collaborators
- Scripps Clinic, Augusta University Medical Center
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecobionics | Experimental | Device: Fecobionics |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must provide written informed consent.
- Age between 21-75 years.
- Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
Key exclusion criteria (7 listed)
- Female who is pregnant or lactating.
- Prior abdominal or anorectal surgery or bowel resection.
- Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
- Confirmed or suspected COVID-19 infection.
- Severe cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FecobionicsAlso: Anorectal manometry, Balloon expulsive testFecobionics 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. | Device | Fecobionics |
Primary outcome
Expulsion Duration
Time frame: 1.5 year
The time it takes to defecate Fecobionics
Pressure Difference between front and rear ends of Fecobionics
Time frame: 1.5 year
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.
4 secondary outcomes
Anorectal angle
Time frame: 1.5 year
Mechanical Tension of Fecobionics
Time frame: 1.5 year
Expulsion Velocity
Time frame: 1.5 year
Cross-sectional area
Time frame: 1.5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecobionics in people with Dyssynergia and Constipation, run by The California Medical Innovations Institute, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Gregersen, PhD (858-249-7400, hag@giome.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion Duration (time frame: 1.5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.