Actively Recruiting
A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
Led by PGP Health · Updated on 2026-04-29
20
Participants Needed
3
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- 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).
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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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
CONTACT
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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