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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot VCS Cohort | Experimental | Wear VCS device for 6+ hours per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variable Compression System | Device | The VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intolerable treatment-related adverse events (AEs) | 21 days | |
| Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IBS-related symptoms | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term impact of VCS use | To assess the long-term change in IBS symptoms after utilizing VCS. | 8 weeks, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agim Beshiri, MD | Contact | +12623448468 | agim.beshiri@cmoproconsult.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Florida Gastro Research | Recruiting | Kissimmee | Florida | 34741 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook | Recruiting | Bolingbrook | Illinois | 60440 | United States |
|
| Delta Gastroenterology PC | Recruiting | Southhaven | Mississippi | 38671 | United States |
|
| D004066 | Digestive System Diseases |