BOOM-IBD2 Pivotal Clinical Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Neuromodulation: Neuromodulation
Study summary
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.
Eligibility
Primary outcome measure(s)
- Bowel Urgency — 12 weeks
Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Gastroenterology Medical Clinic (Objective Health) | Folsom | California | Recruiting |
| Center for Colorectal Innovation | Los Angeles | California | Recruiting |
| Hoag Hospital | Newport Beach | California | Recruiting |
| PAMF (Palo Alto Medical Foundation) | Palo Alto | California | Recruiting |
| Kansas Gastro | Wichita | Kansas | Recruiting |
| MN Urology | Woodbury | Minnesota | Recruiting |
| GI Alliance | Jackson | Mississippi | Recruiting |
| Gateway GI Research (Objective Health) | St Louis | Missouri | Recruiting |
| Las Vegas Medical Research LLC, DBA Vector Clinical Trials | Las Vegas | Nevada | Recruiting |
| Northwell Health North Shore University Hospital | Manhasset | New York | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | Recruiting |
| UNC Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Great Lakes Gastro | Mentor | Ohio | Withdrawn |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Columbia Digestive Health Research (Objective Health) | Columbia | South Carolina | Recruiting |
| Sanford Health | Sioux Falls | South Dakota | Recruiting |
| Amarillo Premier Research (Objective Health) | Amarillo | Texas | Recruiting |
| Digestive Research of Central Texas (Objective Health) | Waco | Texas | Recruiting |
| Digestive Health Research of North Texas (Objective Health) | Wichita Falls | Texas | Active Not Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06571669 on ClinicalTrials.gov ↗ ← All trials in the USA