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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.
The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Patients implanted with neuromodulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation | Device | Neuromodulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Urgency | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Reasner | Contact | 210-722-6192 | deb@boomerangmedical.com | |
| Bruce Van Deman | Contact | 949-413-1301 | bruce@boomerangmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Medical Clinic (Objective Health) | Recruiting | Folsom | California | 95630 | United States |
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| Center for Colorectal Innovation | Recruiting | Los Angeles | California | 90048 | United States |
|
| Hoag Hospital | Recruiting | Newport Beach | California | 92663 | United States |
|
| PAMF (Palo Alto Medical Foundation) | Recruiting | Palo Alto | California | 94301 | United States |
|
| Kansas Gastro | Recruiting | Wichita | Kansas | 67226-8119 | United States |
|
| MN Urology | Recruiting | Woodbury | Minnesota | 55125 | United States |
|
| GI Alliance | Recruiting | Jackson | Mississippi | 39232 | United States |
|
| Gateway GI Research (Objective Health) | Recruiting | St Louis | Missouri | 63141 | United States |
|
| Las Vegas Medical Research LLC, DBA Vector Clinical Trials | Recruiting | Las Vegas | Nevada | 89128 | United States |
|
| Northwell Health North Sore University Hospital | Not yet recruiting | Manhasset | New York | 11030 | United States |
|
| Columbia University Irving Medical Center/New York Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
|
| UNC Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| Great Lakes Gastro | Recruiting | Mentor | Ohio | 44060 | United States |
|
| Pennsylvania Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Columbia Digestive Health Research (Objective Health) | Recruiting | Columbia | South Carolina | 29204 | United States |
|
| Sanford Health | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
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| Amarillo Premier Research (Objective Health) | Recruiting | Amarillo | Texas | 79106 | United States |
|
| Digestive Research of Central Texas (Objective Health) | Recruiting | Waco | Texas | 76712 | United States |
|
| Digestive Health Research of North Texas (Objective Health) | Active, not recruiting | Wichita Falls | Texas | 76301 | United States |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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