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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: IBS (Irritable Bowel Syndrome)
• Intervention / Treatment: Device: Variable Compression System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agim Beshiri, MD; Phone Number: +12623448468; Email: agim.beshiri@cmoproconsult.com

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Central Florida Gastro Research
      • Principal Investigator: Muhammad Mohiuddin, MD
  • Illinois
    • Bolingbrook, Illinois, United States, 60440
      • Recruiting
      • UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
      • Principal Investigator: Hadi Saddiqui, DO, MPH
  • Mississippi
    • Southhaven, Mississippi, United States, 38671
      • Recruiting
      • Delta Gastroenterology PC
      • Principal Investigator: Ulric Duncan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or psychiatric disorders making implementation of the protocol or interpretation of the trial results difficult, or that would put the participant at risk by participating in the trial in the opinion of the Investigator.
• Hospital admission or major surgery within 30 days prior to screening.
• Pregnant, or positive urine pregnancy test.
• Participation in any other investigational drug trial within 30 days prior to screening.
• Participant with substance use disorder (SUD) and/or alcohol use disorder (AUD).
• Participant who has other conditions that may affect compliance in the opinion of the investigator, or who are unable to participate in the trial on his/her own.
• Participant with end stage organ disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot VCS Cohort; Wear VCS device for 6+ hours per day	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of intolerable treatment-related adverse events (AEs)	21 days
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in IBS-related symptoms	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term impact of VCS use	To assess the long-term change in IBS symptoms after utilizing VCS.	8 weeks, 6 months

Collaborators and Investigators

• Sponsor: PGP Health

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; IBS; Variable Compression System; VCS
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: VCS-IBS-11072024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No