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Fecobionics for Constipation

N/A
Recruiting
Research Sponsored by The California Medical Innovations Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
Age between 21-75 years.
Must not have
Prior abdominal or anorectal surgery or bowel resection.
Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a new device to study constipation & pelvic floor dyssynergia in order to improve biofeedback treatments.

Who is the study for?
This trial is for adults aged 21-75 with obstructed defecation/dyssynergia who are undergoing biofeedback therapy at UCSD or Scripps. They must consent to the study's tests. Excluded are those unwilling to consent, with COVID-19, severe heart disease, recent gut surgery, fecal incontinence, or women who are pregnant/breastfeeding.
What is being tested?
The trial is testing a new device called Fecobionics that maps out what happens during bowel movements in patients with dyssynergia. It aims to understand their anorectal function and predict how well they'll respond to biofeedback therapy.
What are the potential side effects?
Since Fecobionics is a diagnostic device rather than a drug, it may have minimal side effects related to discomfort or minor pain during its use for mapping physiological parameters.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have difficulty with bowel movements and am enrolled in the BFT at UCSD or Scripps.
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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery in my abdomen or rectum area before.
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I have been diagnosed with fecal incontinence and experience symptoms or take medications that affect my anorectal function.
Select...
I have or might have COVID-19.
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I have severe heart problems.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Expulsion Duration
Pressure Difference between front and rear ends of Fecobionics
Secondary study objectives
Anorectal angle
Cross-sectional area
Expulsion Velocity
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FecobionicsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecobionics
2021
N/A
~50

Find a Location

Who is running the clinical trial?

The California Medical Innovations Institute, Inc.Lead Sponsor
2 Previous Clinical Trials
190 Total Patients Enrolled
Scripps ClinicOTHER
14 Previous Clinical Trials
28,489 Total Patients Enrolled

Media Library

Fecobionics (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05807321 — N/A
Dyscoordination Research Study Groups: Fecobionics
Dyscoordination Clinical Trial 2023: Fecobionics Highlights & Side Effects. Trial Name: NCT05807321 — N/A
Fecobionics (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05807321 — N/A
~1 spots leftby Jan 2025
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