Variable Compression System: The VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of intolerable treatment-related adverse events (AEs) — 21 days
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs) — 21 days
Trial sites (3)
Facility
City
Region
Status
Central Florida Gastro Research
Kissimmee
Florida
Recruiting
UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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