BOOM-IBD2 Pivotal Neuromodulation for Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial implants a small neuromodulation device under the skin near the tailbone during a same-day procedure to deliver mild electrical signals to a nearby nerve. All enrolled adults (ages 18–85) with ulcerative colitis receive the device; there is no placebo or sham group. The primary outcome is change in bowel urgency at 12 weeks measured with a standard urgency rating scale, and participants are followed with visits for 12 months. The approach aims to alter neural signaling to improve urgency and related bowel symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Gastroenterology Medical Clinic (Objective Health)
  Folsom, California, United States Recruiting
• Center for Colorectal Innovation
  Los Angeles, California, United States Recruiting
• Hoag Hospital
  Newport Beach, California, United States Recruiting
• PAMF (Palo Alto Medical Foundation)
  Palo Alto, California, United States Recruiting
• Kansas Gastro
  Wichita, Kansas, United States Recruiting
• MN Urology
  Woodbury, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Deborah Reasner
• Email: deb@boomerangmedical.com
• Phone: 210-722-6192

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

  This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.

  Recruiting at 4 sites Phase 2 Athos Therapeutics Inc · Miami, Florida and 3 other locations · NCT07513181

• Self-management program to improve health in inflammatory bowel disease

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  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07456566

• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

  This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.

  Recruiting Phase 1 University of Alberta · Calgary, Alberta and 1 other locations · NCT07401680

• Long-acting antibody treatments alone and in combinations for moderate to severe ulcerative colitis

  This tests long-acting antibody medicines, given after an IV induction and then as under-the-skin maintenance, to see if they help adults with moderate to severe ulcerative colitis.

  Recruiting at 276 sites Phase 2 Spyre Therapeutics, Inc. · Canoga Park, California and 275 other locations · NCT07012395

• Observational study comparing inflammatory markers in IBD and non-IBD participants

  This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

  Recruiting University of Nottingham · Nottingham, Nottinghamshire · NCT06956703

• Evaluating robotic surgery for inflammatory bowel disease

  This study is testing if robotic surgery can be a good option for adults with inflammatory bowel disease, like Crohn's or ulcerative colitis, compared to traditional surgery methods.

  Recruiting at 6 sites University Hospitals Coventry and Warwickshire NHS Trust · Coventry, West Midlands and 5 other locations · NCT06579443

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.