A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
Key facts
- Where
- Bolingbrook, Kissimmee, and Southhaven, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07540312, who can take part
Where in United States
- UChicago Medicine AdventHealth Medical Group Gastroenterology at BolingbrookBolingbrook, United StatesContact: Hadi Saddiqui, DO, MPH (principal investigator)Taking people
- Central Florida Gastro ResearchKissimmee, United StatesContact: Muhammad Mohiuddin, MD (principal investigator)Taking people
- Delta Gastroenterology PCSouthhaven, United StatesContact: Ulric Duncan, MD (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- PGP Health
- Trial code
- NCT07540312
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
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 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.
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; Hospital admission or major surgery within 30 days prior to screening; Participation in any other investigational drug trial within 30 days prior to screening; 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; 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; Pregnant, or positive urine pregnancy test.