🔎 Trials Near Me

Home › Ulcerative Colitis › NCT06571669

BOOM-IBD2 Pivotal Clinical Trial

Recruiting

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

Who can join

Ages 18 to 85 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Male or female
* 18 to 85 years of age
* Diagnosed with ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow up requirements

Exclusion Criteria:

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* Current evidence of cancer in the gastrointestinal tract
* Current participation in another clinical trial
* Previous history of surgery for ulcerative colitis, or probably to require such intervention
* Previously implanted with a neurostimulation device or participated in a neurostimulation trial
* Inability to operate the patient programmer

About the study

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.

What is being tested

Sponsor: Boomerang Medical · Participants: 137 · Started: Jan 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06571669

Locations in the U.S.

CaliforniaGastroenterology Medical Clinic (Objective Health), Folsom
Center for Colorectal Innovation, Los Angeles
Hoag Hospital, Newport Beach
PAMF (Palo Alto Medical Foundation), Palo Alto
KansasKansas Gastro, Wichita
MinnesotaMN Urology, Woodbury
MississippiGI Alliance, Jackson
MissouriGateway GI Research (Objective Health), St Louis
NevadaLas Vegas Medical Research LLC, DBA Vector Clinical Trials, Las Vegas
New YorkNorthwell Health North Shore University Hospital, Manhasset
Columbia University Irving Medical Center/New York Presbyterian Hospital, New York
North CarolinaUNC Chapel Hill, Chapel Hill
PennsylvaniaPennsylvania Hospital, Philadelphia (Not yet recruiting)
South CarolinaColumbia Digestive Health Research (Objective Health), Columbia
South DakotaSanford Health, Sioux Falls
TexasAmarillo Premier Research (Objective Health), Amarillo
Digestive Research of Central Texas (Objective Health), Waco

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.