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BOOM-IBD2 Pivotal Clinical Trial

Boomerang Medical · NCT06571669

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
137
US sites recruiting
16
Study start
January 31, 2025
Record last updated
August 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Neuromodulation

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Gastroenterology Medical Clinic (Objective Health)

    Folsom, CA 95630

    Site contact: Clinical Trial Coordinator · 916-226-6044 · grecia.perez@objective.health

  • Center for Colorectal Innovation

    Los Angeles, CA 90048

    Site contact: Clinical Trial Coordinator · (310) 289-9224 · Gayane.Ovsepyan@cshs.org

  • Hoag Hospital

    Newport Beach, CA 92663

    Site contact: Clinical Trial Coordinator · 949-764-5597 · Vianh.Truong@hoag.org

  • PAMF (Palo Alto Medical Foundation)

    Palo Alto, CA 94301

    Site contact: Clinical Trial Coordinator · 510-204-1609 · myesha.kirk@sutterhealth.org

  • Kansas Gastro

    Wichita, KS 67226-8119

    Site contact: Clinical Trial Coordinator · (316) 730-1029 · jessica_wewer@ksgastro.com

  • MN Urology

    Woodbury, MN 55125

    Site contact: Clinical Research Manager · 651-999-6903 · cmckenzie@mnurology.com

  • GI Alliance

    Jackson, MS 39232

    Site contact: Clinical Trial Coordinator · 601-863-0395 · jesus.monico@gastrodocs.net

  • Gateway GI Research (Objective Health)

    St Louis, MO 63141

    Site contact: Clinical Trial Coordinator · 636-214-5291 · kristen.strubberg@objective.health

  • Las Vegas Medical Research LLC, DBA Vector Clinical Trials

    Las Vegas, NV 89128

    Site contact: Clinical Trial Coordinator · +1 702-750-0000 · betsyj@vectorclinicaltrials.com

  • Northwell Health North Shore University Hospital

    Manhasset, NY 11030

    Site contact: Clinical Trial Coordinator · 516-504-3955 · mmanoharan@northwell.edu

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    New York, NY 10032

    Site contact: Clinical Trial Coordinator · 212-342-4102 · eb3709@cumc.columbia.edu

  • UNC Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Clinical Trial Coordinator · 919-843-8105 · emily_english@med.unc.edu

  • Columbia Digestive Health Research (Objective Health)

    Columbia, SC 29204

    Site contact: Clinical Trial Coordinator · 803-386-8933 · marissa.white@objective.health

  • Sanford Health

    Sioux Falls, SD 57105

    Site contact: Clinical Trial Coordinator · 605-328-1379 · ashley.puetz@sanfordhealth.org

  • Amarillo Premier Research (Objective Health)

    Amarillo, TX 79106

    Site contact: Clinical Trial Coordinator · 806-641-0256 · lauren.kuehler@objective.health

  • Digestive Research of Central Texas (Objective Health)

    Waco, TX 76712

    Site contact: (254) 523-4187 · Victoria.Rico@objective.health

Study contacts (from the official record)

  • Deborah Reasner · 210-722-6192 · deb@boomerangmedical.com
  • Bruce Van Deman · 949-413-1301 · bruce@boomerangmedical.com
BOOM-IBD2 Pivotal Clinical Trial (NCT06571669) | Bored Studies