RECRUITING

BOOM-IBD2 Pivotal Clinical Trial

Description

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.

Conditions

Ulcerative ColitisInflammatory Bowel Diseases
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Related Conditions:

Ulcerative ColitisInflammatory Bowel Diseases

Study Overview

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Study Details

Study overview

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.

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

BOOM-IBD2 Pivotal Clinical Trial

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Center for Colorectal Innovation, Los Angeles, California, United States, 90048

Newport Beach

Hoag Hospital, Newport Beach, California, United States, 92663

Palo Alto

PAMF (Palo Alto Medical Foundation), Palo Alto, California, United States, 94301

Wichita

Kansas Gastro, Wichita, Kansas, United States, 67226-8119

St. Louis

Objective Health - St. Louis, St. Louis, Missouri, United States, 63141

Las Vegas

Las Vegas Medical Research LLC, DBA Vector Clinical Trials, Las Vegas, Nevada, United States, 89113

New York

Columbia University Irving Medical Center/New York Presbyterian Hospital, New York, New York, United States, 10032

Chapel Hill

UNC Chapel Hill, Chapel Hill, North Carolina, United States, 27599-1350

Amarillo

Objective Health - Amarillo, Amarillo, Texas, United States, 79106

Waco

Objective Health - Central Texas, Waco, Texas, United States, 76712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boomerang Medical,

Study Record Dates

2026-10