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RecruitingNCT07540312Updated Apr 29, 2026

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

An interventional study of Variable Compression System in IBS (Irritable Bowel Syndrome), sponsored by PGP Health. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by PGP Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled May 2025, registered Apr 2026).
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • IBS (Irritable Bowel Syndrome)

Keywords

  • Variable Compression System
  • VCS
  • Irritable Bowel Syndrome
  • IBS
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 20 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

This is the only study on the registry with PGP Health as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Pilot VCS Cohort

    Wear VCS device for 6+ hours per day

    Device: Variable Compression System

Interventions

  • DeviceVariable 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).

06

What researchers measure

Primary outcomes

  1. Incidence of intolerable treatment-related adverse events (AEs)

    Time frame: 21 days

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

    Time frame: 21 days

Secondary outcomes

  1. Change in IBS-related symptoms

    Time frame: 21 days

Other outcomes

  1. Long-term impact of VCS use

    To assess the long-term change in IBS symptoms after utilizing VCS.

    Time frame: 8 weeks, 6 months

07

Study locations

3 of 3 sites recruiting
  • Central Florida Gastro Research
    Kissimmee, Florida 34741, United States
    • Muhammad Mohiuddin, MD · Principal investigator
    Recruiting
  • UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
    Bolingbrook, Illinois 60440, United States
    • Hadi Saddiqui, DO, MPH · Principal investigator
    Recruiting
  • Delta Gastroenterology PC
    Southhaven, Mississippi 38671, United States
    • Ulric Duncan, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07540312
Lead sponsor
PGP Health
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
May 21, 2025
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Agim Beshiri, MD
Contact
agim.beshiri@cmoproconsult.com
+12623448468

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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