Study of a Wearable Variable Compression System Device for Adults Aged 18 to 60 With Moderate to Severe Irritable Bowel Syndrome

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.

A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome