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

NCT07540312 | Recruiting DMC FDA Device

• 1 other identifier: VCS-IBS-11072024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

IBS (Irritable Bowel Syndrome)

Keywords

Variable Compression System; VCS; Irritable Bowel Syndrome; IBS

Outcome Measures

Primary Outcomes (2)

• Incidence of intolerable treatment-related adverse events (AEs)

  21 days

• Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)

  21 days

Secondary Outcomes (1)

• Change in IBS-related symptoms

  21 days

Other Outcomes (1)

• Long-term impact of VCS use

  8 weeks, 6 months

Study Arms (1)

Pilot VCS Cohort

EXPERIMENTAL

Wear VCS device for 6+ hours per day

Device: Variable Compression System

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).

Pilot VCS Cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• PGP Health: lead

Study Sites (3)

Central Florida Gastro Research

Kissimmee, Florida, 34741, United States

RECRUITING

UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook

Bolingbrook, Illinois, 60440, United States

RECRUITING

Delta Gastroenterology PC

Southhaven, Mississippi, 38671, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Agim Beshiri, MD

CONTACT

+12623448468; agim.beshiri@cmoproconsult.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: May 21, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (3)