A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
Purpose
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.
Condition
- IBS (Irritable Bowel Syndrome)
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pilot Cohort |
Wear VCS device for 6+ hours per day |
|
Recruiting Locations
Central Florida Gastro Research
Kissimmee, Florida 34741
Kissimmee, Florida 34741
UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
Bolingbrook, Illinois 60440
Bolingbrook, Illinois 60440
Delta Gastroenterology PC
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
More Details
- Status
- Recruiting
- Sponsor
- PGP Health