RECRUITING

BOOM-IBD2 Pivotal Clinical Trial

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Conditions

Ulcerative ColitisInflammatory Bowel Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-31
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06571669

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female
  2. * 18 to 85 years of age
  3. * Diagnosed with ulcerative colitis
  4. * Ability and willingness to consent to participate by signing the informed consent form
  5. * Ability to comply with the protocol and willingness to comply with all follow up requirements
  1. * Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
  2. * Any psychiatric or personality disorder at the discretion of the study investigator
  3. * Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
  4. * Active clostridium difficile infection of the colon
  5. * Active cytomegalovirus (CMV) infection of the colon
  6. * Evidence of colonic perforation
  7. * Fulminant colitis requiring emergency surgery
  8. * Microscopic, ischemic or infectious colitis
  9. * Unresected neoplasia of the colon
  10. * Colonic stricture unable to pass a colonoscope
  11. * Current evidence of cancer in the gastrointestinal tract
  12. * Current participation in another clinical trial
  13. * Previous history of surgery for ulcerative colitis, or probably to require such intervention
  14. * Previously implanted with a neurostimulation device or participated in a neurostimulation trial
  15. * Inability to operate the patient programmer

Contacts and Locations

Study Contact

Malea D'Amico
CONTACT
844-423-9747
mdamico@boomerangmedical.com
Colleen Holthe
CONTACT
844-423-9747
colleen@boomerangmedical.com

Study Locations (Sites)

Center for Colorectal Innovation
Los Angeles, California, 90048
United States
Hoag Hospital
Newport Beach, California, 92663
United States
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, 94301
United States
Kansas Gastro
Wichita, Kansas, 67226-8119
United States
Objective Health - St. Louis
St. Louis, Missouri, 63141
United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, 89113
United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599-1350
United States
Objective Health - Amarillo
Amarillo, Texas, 79106
United States
Objective Health - Central Texas
Waco, Texas, 76712
United States

Collaborators and Investigators

Sponsor: Boomerang Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Inflammatory Bowel Diseases