BOOM-IBD2 Pivotal Clinical Trial
Part of paid clinical trials in Folsom, California.
- Sponsor
- Boomerang Medical
- Study ID
- NCT06571669
- Status
- Recruiting
Conditions
- Inflammatory Bowel Diseases
- Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Neuromodulation — DEVICENeuromodulation
Study Details
Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.
Key Dates
- Start date
- Jan 31, 2025
- Status verified
- May 2026
- Primary completion
- Feb 28, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 137 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment ArmPatients implanted with neuromodulation
Primary Outcome Measure
Bowel Urgency [ Time Frame: 12 weeks ]
Central Contacts
- Deborah Reasner210-722-6192
- Bruce Van Deman949-413-1301
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gastroenterology Medical Clinic (Objective Health) | Folsom | California | 95630 | Nazir Rahim, MD (PRINCIPAL_INVESTIGATOR) |
| Center for Colorectal Innovation | Los Angeles | California | 90048 | Karen Zaghiyan (PRINCIPAL_INVESTIGATOR) |
| Hoag Hospital | Newport Beach | California | 92663 | Caroline Hwang (PRINCIPAL_INVESTIGATOR) |
| PAMF (Palo Alto Medical Foundation) | Palo Alto | California | 94301 | Ryan McConnell (PRINCIPAL_INVESTIGATOR) |
| Kansas Gastro | Wichita | Kansas | 67226-8119 | Michael Lievens, MD (PRINCIPAL_INVESTIGATOR) |
| MN Urology | Woodbury | Minnesota | 55125 | Jodi Michaels, MD (PRINCIPAL_INVESTIGATOR) |
| GI Alliance | Jackson | Mississippi | 39232 | Reed Hogan, MD (PRINCIPAL_INVESTIGATOR) |
| Gateway GI Research (Objective Health) | St Louis | Missouri | 63141 | Brian McMorrow, MD (PRINCIPAL_INVESTIGATOR) |
| Las Vegas Medical Research LLC, DBA Vector Clinical Trials | Las Vegas | Nevada | 89128 | Christian Stone (PRINCIPAL_INVESTIGATOR) |
| Northwell Health North Sore University Hospital | Manhasset | New York | 11030 | Keith Sultan, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | Marco Zoccali, MD (PRINCIPAL_INVESTIGATOR) |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | Millie Long, MD (PRINCIPAL_INVESTIGATOR) |
| Great Lakes Gastro | Mentor | Ohio | 44060 | Keith Friedenberg, MD (PRINCIPAL_INVESTIGATOR) |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | Joshua Bleier, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia Digestive Health Research (Objective Health) | Columbia | South Carolina | 29204 | Edward Kimbrough, MD (PRINCIPAL_INVESTIGATOR) |
| Sanford Health | Sioux Falls | South Dakota | 57105 | Kevin Benson, MD (PRINCIPAL_INVESTIGATOR) |
| Amarillo Premier Research (Objective Health) | Amarillo | Texas | 79106 | Susan Neese (PRINCIPAL_INVESTIGATOR) |
| Digestive Research of Central Texas (Objective Health) | Waco | Texas | 76712 | (254) 523-4187 Hanumantha Ancha (PRINCIPAL_INVESTIGATOR) |
| Digestive Health Research of North Texas (Objective Health) | Wichita Falls | Texas | 76301 | Louis Wilson, MD (PRINCIPAL_INVESTIGATOR) |
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