A Prospective Interventional Trial With a Non-invasive Variable Compression System (VCS) to Determine the Efficacy in Patients With Moderate to Severe Irritable Bowel Syndrome (IBS)

PGP Health

Summary

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.

Eligibility

Age range: 18–60 years
Sex: All
Healthy volunteers: No

Detailed 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 to severe). Exclusion Criteria: * Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator. * Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hem…

Interventions

Device
Variable Compression System
The VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR).

Locations (3)

Central Florida Gastro Research
Kissimmee, Florida
UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
Bolingbrook, Illinois
Delta Gastroenterology PC
Southhaven, Mississippi

A Prospective Interventional Trial With a Non-invasive Variable Compression System (VCS) to Determine the Efficacy in Patients With Moderate to Severe Irritable Bowel Syndrome (IBS)

Summary

Eligibility

Interventions

Locations (3)

Compensation

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Details

Conditions