Recruiting

Sacral NeuromodulationBOOM-IBD2 Pivotal Clinical Trial

Sponsor:

Boomerang Medical

Code:

NCT06571669

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuromodulation

Study Details

Brief 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.

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Study ID

NCT06571669

Start date

Jan 31, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

137 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Patients implanted with neuromodulation

Interventions

Neuromodulation

Primary outcome measure

Bowel Urgency [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Deborah Reasner

210-722-6192 deb@boomerangmedical.com

Bruce Van Deman

949-413-1301 bruce@boomerangmedical.com

Locations

Gastroenterology Medical Clinic (Objective Health)

Recruiting

Folsom, California, United States, 95630

Contacts

Clinical Trial Coordinator

916-226-6044 grecia.perez@objective.health

Principal Investigator:

Nazir Rahim, MD

Center for Colorectal Innovation

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Coordinator

(310) 289-9224 Gayane.Ovsepyan@cshs.org

Principal Investigator:

Karen Zaghiyan

Hoag Hospital

Recruiting

Newport Beach, California, United States, 92663

Contacts

Clinical Trial Coordinator

949-764-5597 Vianh.Truong@hoag.org

Principal Investigator:

Caroline Hwang

PAMF (Palo Alto Medical Foundation)

Recruiting

Palo Alto, California, United States, 94301

Contacts

Clinical Trial Coordinator

510-204-1609 myesha.kirk@sutterhealth.org

Principal Investigator:

Ryan McConnell

Kansas Gastro

Recruiting

Wichita, Kansas, United States, 67226-8119

Contacts

Clinical Trial Coordinator

(316) 730-1029 jessica_wewer@ksgastro.com

Principal Investigator:

Michael Lievens, MD

MN Urology

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Clinical Research Manager

651-999-6903 cmckenzie@mnurology.com

Principal Investigator:

Jodi Michaels, MD

GI Alliance

Recruiting

Jackson, Mississippi, United States, 39232

Contacts

Clinical Trial Coordinator

601-863-0395 jesus.monico@gastrodocs.net

Principal Investigator:

Reed Hogan, MD

Gateway GI Research (Objective Health)

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Clinical Trial Coordinator

636-214-5291 kristen.strubberg@objective.health

Principal Investigator:

Brian McMorrow, MD

Las Vegas Medical Research LLC, DBA Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Clinical Trial Coordinator

+1 702-750-0000 betsyj@vectorclinicaltrials.com

Principal Investigator:

Christian Stone

Northwell Health North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Clinical Trial Coordinator

516-504-3955 mmanoharan@northwell.edu

Principal Investigator:

Keith Sultan, MD

Columbia University Irving Medical Center/New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Clinical Trial Coordinator

212-342-4102 eb3709@cumc.columbia.edu

Principal Investigator:

Marco Zoccali, MD

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Clinical Trial Coordinator

919-843-8105 emily_english@med.unc.edu

Principal Investigator:

Millie Long, MD

Columbia Digestive Health Research (Objective Health)

Recruiting

Columbia, South Carolina, United States, 29204

Contacts

Clinical Trial Coordinator

803-386-8933 marissa.white@objective.health

Principal Investigator:

Edward Kimbrough, MD

Sanford Health

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Clinical Trial Coordinator

605-328-1379 ashley.puetz@sanfordhealth.org

Principal Investigator:

Kevin Benson, MD

Amarillo Premier Research (Objective Health)

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Clinical Trial Coordinator

806-641-0256 lauren.kuehler@objective.health

Principal Investigator:

Susan Neese

Digestive Research of Central Texas (Objective Health)

Recruiting

Waco, Texas, United States, 76712

Contacts

(254) 523-4187 Victoria.Rico@objective.health

Principal Investigator:

Hanumantha Ancha

More Information

Sponsor

Boomerang Medical

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boomerang Medical on 2026-08-06.