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

Part of paid clinical trials in Kissimmee, Florida.

Sponsor
PGP Health
Study ID
NCT07540312
Status
Recruiting
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Conditions

  • IBS (Irritable Bowel Syndrome)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 21, 2025
Status verified
Apr 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pilot VCS Cohort
    Wear VCS device for 6+ hours per day

Primary Outcome Measure

Incidence of intolerable treatment-related adverse events (AEs) [ Time Frame: 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Central Florida Gastro ResearchKissimmeeFlorida34741
Muhammad Mohiuddin, MD (PRINCIPAL_INVESTIGATOR)
UChicago Medicine AdventHealth Medical Group Gastroenterology at BolingbrookBolingbrookIllinois60440
Hadi Saddiqui, DO, MPH (PRINCIPAL_INVESTIGATOR)
Delta Gastroenterology PCSouthhavenMississippi38671
Ulric Duncan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kissimmee, FL

By research site
Central Florida Gastro Research· Kissimmee, FLUChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook· Bolingbrook, ILDelta Gastroenterology PC· Southhaven, MS

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