A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Variable Compression System.
- Who it may be relevant to
- Registry conditions: IBS (Irritable Bowel Syndrome). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Device 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).
Primary outcome measures
- Incidence of intolerable treatment-related adverse events (AEs) [Time frame: 21 days]
- Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs) [Time frame: 21 days]
Secondary outcome measures (1)
- Change in IBS-related symptoms [Time frame: 21 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Central Florida Gastro Research — Kissimmee
- UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook — Bolingbrook
- Delta Gastroenterology PC — Southhaven
Identifiers
NCT: NCT07540312 · VCS-IBS-11072024