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.
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).
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.
Single group
Variable Compression System
DeviceThe VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR).
Incidence of intolerable treatment-related adverse events (AEs)
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)
Change in IBS-related symptoms
Long-term impact of VCS use
To assess the long-term change in IBS symptoms after utilizing VCS.
