Boom-IBD Clinical Trial

Last updated: June 26, 2025
Sponsor: Boomerang Medical
Overall Status: Completed

Phase

N/A

Condition

Inflammatory Bowel Disease

Treatment

Neuromodulation

Clinical Study ID

NCT05414955
Boom-IBD
  • Ages 18-75
  • All Genders

Study Summary

Feasibility study of neuromodulation in patients with IBD.

Eligibility Criteria

Inclusion

General Inclusion Criteria:

  • Male or female

  • 18 to 75 years of age

  • Diagnosed with Crohn's Disease or 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

  • Still have part or all of their colon

General Exclusion Criteria (The subject must not meet ANY of the following 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

  • History of cancer including melanoma (except for localized skin cancers) within 2 years

  • Participation in another clinical trial within the past 30 days of device implant

  • Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant

  • Inability to operate the patient programmer

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Neuromodulation
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
December 06, 2024

Study Description

The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Connect with a study center

  • Reliance Research

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Phillip Fleshner, Inc.

    Los Angeles, California 90048
    United States

    Site Not Available

  • Palo Alto Medical Foundation Research Institute

    Palo Alto, California 94301
    United States

    Site Not Available

  • CU Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Kansas Gastroenterology

    Wichita, Kansas 67226-8119
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • The Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Colon Surgeons of Charleston

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.