A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome

Recruiting N/A Interventional Study
IBS (Irritable Bowel Syndrome)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
PGP Health · Industry
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About This Trial

This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Written informed consent to participate in the trial as prescribed. * Subjects with a weight of ≥50 kg and a body mass index between 18 and 40 kg/m2. * Diagnosed with IBS(C)-constipation, IBS(D)-diarrhea, or IBS(M)-mixed patients' diagnosis according to Rome Criteria (moderate…
Contacts

Agim Beshiri, MD

+12623448468

agim.beshiri@cmoproconsult.com

CONTACT