IBS (Irritable Bowel Syndrome)
Conditions
Keywords
Variable Compression System, VCS, Irritable Bowel Syndrome, IBS
Brief 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.
Interventions
DEVICEVariable 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).
Sponsors
PGP Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intolerable treatment-related adverse events (AEs) | 21 days |
| Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs) | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Change in IBS-related symptoms | 21 days |
Countries
United States
Contacts
CONTACTAgim Beshiri, MD
Outcome results
None listed