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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have difficulty with bowel movements and am enrolled in the BFT at UCSD or Scripps.

Select...

I am between 21 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expulsion Duration

Pressure Difference between front and rear ends of Fecobionics

Secondary outcome measures

Anorectal angle

Cross-sectional area

Expulsion Velocity

+1 more

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

0 / 2Eligibility criteria met

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

13 Previous Clinical Trials

28,413 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this trial open to enrollment?

"Qualified individuals for this trial must demonstrate dyscoordination and be between 21 and 75 years old. The recruitment is set to include 24 participants in total."

Answered by AI

Are there still vacancies for participants in this research?

"According to the clinicaltrials.gov data, this trial is no longer accepting participants; it was initially posted on April 1st 2023 and last updated March 29th 2023. Nonetheless, there are still 127 other medical studies actively seeking enrolment at present."

Answered by AI

Are older individuals excluded from participating in this clinical research?

"This medical trial seeks participants aged 21-75 years. There are 41 studies for minors and 88 for seniors."

Answered by AI

What are the ultimate aims of this experiment?

"This long-term trial, with a projected timeline of 1.5 years, seeks to measure the Pressure Difference between front and rear ends of Fecobionics. Secondary objectives include assessing Mechanical Tension (determined by anorectal radius multiply pressure), Expulsion Velocity (measured from sensor data time difference) and Cross-sectional area (calculated using diameter)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Hans Gregersen, PhD 2023. "Fecobionics in Biofeedback Therapy in Dyssynergia Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807321.

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