RecruitingNot ApplicableNCT06571669

BOOM-IBD2 Pivotal Clinical Trial

BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.

Sponsor

Boomerang Medical

Enrollment

137 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Ulcerative Colitis

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This pivotal clinical trial tests an investigational device or treatment (BOOM) for ulcerative colitis (UC) — a chronic inflammatory bowel disease that causes ongoing inflammation and ulcers in the lining of the large intestine, leading to diarrhea, pain, and bleeding. The study aims to confirm that the BOOM intervention is safe and effective. **You may be eligible if:** - You are between 18 and 85 years old - You have a confirmed diagnosis of ulcerative colitis - You are able and willing to consent and attend all follow-up visits **You may NOT be eligible if:** - You have a serious medical condition that may interfere with the study or confound results - You have an active bacterial infection posing a risk of sepsis (e.g., abscess) - You have active C. difficile or cytomegalovirus (CMV) infection in the colon - You have evidence of a hole in the colon (perforation) or need emergency surgery - You have a colonic tumor that has not been removed - You have a psychiatric or personality disorder at the investigator's discretion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeuromodulation

Neuromodulation

Locations(19)

Gastroenterology Medical Clinic (Objective Health)

Folsom, California, United States

Center for Colorectal Innovation

Los Angeles, California, United States

Hoag Hospital

Newport Beach, California, United States

PAMF (Palo Alto Medical Foundation)

Palo Alto, California, United States

Kansas Gastro

Wichita, Kansas, United States

MN Urology

Woodbury, Minnesota, United States

GI Alliance

Jackson, Mississippi, United States

Gateway GI Research (Objective Health)

St Louis, Missouri, United States

Las Vegas Medical Research LLC, DBA Vector Clinical Trials

Las Vegas, Nevada, United States

Northwell Health North Sore University Hospital

Manhasset, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Great Lakes Gastro

Mentor, Ohio, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Columbia Digestive Health Research (Objective Health)

Columbia, South Carolina, United States

Sanford Health

Sioux Falls, South Dakota, United States

Amarillo Premier Research (Objective Health)

Amarillo, Texas, United States

Digestive Research of Central Texas (Objective Health)

Waco, Texas, United States

Digestive Health Research of North Texas (Objective Health)

Wichita Falls, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06571669

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