Actively Recruiting
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)
Led by PGP Health · Updated on 2026-04-29
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Variable Compression System (VCS) device for adults with moderate to severe Irritable Bowel Syndrome (IBS), including constipation-predominant, diarrhea-predominant, or mixed types based on Rome Criteria. This pilot, interventional trial aims to understand how well this wearable device works in managing IBS symptoms and its potential side effects. The study involves wearing the VCS device, which provides compression to the lower abdomen, torso support, and emits Far Infrared Radiation (FIR) over the torso. Participants will wear the device for at least 6 hours daily. Follow-up visits are scheduled at 21 days, 8 weeks, and 6 months after starting to use the device to monitor progress and gather data. During the study, participants will be assessed for any treatment-related side effects, including intolerable and emergent adverse events within 21 days. Researchers will also track changes in IBS symptoms. The total participation includes monitoring over several months, with evaluations at multiple time points to understand both safety and symptom changes over time.
CONDITIONS
Brief Title
A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent to participate
- Weigh at least 50 kg
- Have a body mass index (BMI) between 18 and 40 kg/m2
- Diagnosed with moderate to severe IBS (constipation, diarrhea, or mixed type) according to Rome Criteria
You will not qualify if you...
- Allergy to the investigational device or its components, or significant allergies beyond mild seasonal allergies
- History of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or psychiatric disorders that complicate trial participation or results
- Hospital admission or major surgery within 30 days before screening
- Pregnant or positive pregnancy test
- Participation in another investigational drug trial within 30 days before screening
- Substance use disorder or alcohol use disorder
- Conditions impacting compliance or inability to participate independently
- End stage organ disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants wear the Variable Compression System (VCS) device for 6 or more hours per day to provide compression of the lower abdomen, torso support, and Far Infrared Radiation (FIR) coverage.
Approximately 3 visits during the 21 days
Trial Site Locations
Total: 3 locations
1
Central Florida Gastro Research
Kissimmee, Florida, United States, 34741
Actively Recruiting
2
UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
Bolingbrook, Illinois, United States, 60440
Actively Recruiting
3
Delta Gastroenterology PC
Southhaven, Mississippi, United States, 38671
Actively Recruiting
Research Team
A
Agim Beshiri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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