Recruiting

Variable Compression System

Sponsor:

PGP Health

Code:

NCT07540312

Conditions

IBS (Irritable Bowel Syndrome)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Variable Compression System

Study Details

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)

Study ID

NCT07540312

Start date

May 21, 2025

Status verified date

Apr, 2026

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pilot VCS Cohort

Wear VCS device for 6+ hours per day

Interventions

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).

Primary outcome measure

  • Incidence of intolerable treatment-related adverse events (AEs) [ Time Frame: 21 days ]
  • Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs) [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Agim Beshiri, MD

+12623448468agim.beshiri@cmoproconsult.com

Locations

Central Florida Gastro Research

Recruiting

Kissimmee, Florida, United States, 34741

Principal Investigator:

Muhammad Mohiuddin, MD

UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook

Recruiting

Bolingbrook, Illinois, United States, 60440

Principal Investigator:

Hadi Saddiqui, DO, MPH

Delta Gastroenterology PC

Recruiting

Southhaven, Mississippi, United States, 38671

Principal Investigator:

Ulric Duncan, MD

More Information

Sponsor

PGP Health

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PGP Health on 2026-04-29.