Variable Compression System for moderate to severe IBS

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 pilot will try a wearable Variable Compression System device for adults with moderate to severe IBS to see if wearing it reduces symptoms and is safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: PGP Health (Industry-sponsored)
• Locations: 3 sites (Kissimmee, Florida and 2 other locations)
• Trial ID: NCT07540312 on ClinicalTrials.gov

What this trial studies

This is a prospective interventional pilot of a wearable Variable Compression System (VCS) for adults with moderate to severe irritable bowel syndrome. The study plans to enroll 20 participants who must wear the VCS device for at least six hours each day. Participants will be seen at baseline and followed at 21 days, 8 weeks, and 6 months to monitor safety and symptom change. The trial aims to gather preliminary data on tolerability and effectiveness to inform larger studies.

Who should consider this trial

Good fit: Adults with moderate to severe IBS (constipation-, diarrhea-, or mixed-predominant) who meet the device criteria of weight ≥50 kg and BMI 18–40 kg/m2 and can comply with daily wear are ideal candidates.

Not a fit: Patients with device allergies, significant comorbid conditions that were excluded, recent major surgery, or those unable to wear the device for the required time may not benefit from participation.

Why it matters

Potential benefit: If successful, the device could offer a non-drug, wearable option to reduce IBS symptoms for some patients.

How similar studies have performed: There are limited prior clinical data on this specific device and wearable abdominal compression for IBS is largely untested in rigorous trials.

Eligibility criteria

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.

Where this trial is running

Kissimmee, Florida and 2 other locations

• Central Florida Gastro Research — Kissimmee, Florida, United States (Recruiting)
• UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook — Bolingbrook, Illinois, United States (Recruiting)
• Delta Gastroenterology PC — Southhaven, Mississippi, United States (Recruiting)

Study contacts

• Study coordinator: Agim Beshiri, MD

Conditions IBS; Variable Compression System; VCS; Irritable Bowel Syndrome