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Variable Compression System for Moderate to Severe Irritable Bowel Syndrome

This study is testing a device called the Variable Compression System (VCS) for people with moderate to severe Irritable Bowel Syndrome (IBS). The VCS is a wearable device that provides compression to the lower abdomen, supports the torso, and covers the torso in Far Infrared Radiation (FIR). Researchers want to see how safe and effective this device is. They will be looking at any side effects that happen during the study. You may be able to join if you are between 18 and 60 years old, weigh at least 50 kg, and have a BMI between 18 and 40. You also need to have been diagnosed with IBS (constipation, diarrhea, or mixed type) according to specific medical guidelines. This study is currently unclear about its recruitment status.

Study design
This is a pilot study, meaning it's a small-scale test, and plans to enroll 20 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would need to wear the VCS device for at least 6 hours a day. You will have follow-up appointments at 21 days, 8 weeks, and 6 months after starting to use the device.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting to use the device.

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NCT07540312

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

Recruiting
NAAges 18–60InterventionalTreatment
PGP Health
~20 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Variable Compression System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of intolerable treatment-related adverse events (AEs)
Measured over 21 days
+1 more outcome measured

Conditions

IBS (Irritable Bowel Syndrome)

Explore related trials

Irritable Bowel Syndrome

Where it's being run

3 sites across 3 states
Florida1
Illinois1
Mississippi1

Who to contact

Agim Beshiri, MD
[email protected]
+12623448468
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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