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BOOM-IBD2 Pivotal Clinical Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study visits continue for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a small device under the skin can reduce the sudden need to have a bowel movement. It is for adults ages 18 to 85 with ulcerative colitis, a long-term illness that causes swelling and sores in the large intestine. The device sends mild signals to a nerve near the tailbone and is placed during a same-day procedure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 85, male or female.
  • Have ulcerative colitis.
  • Able and willing to sign a form agreeing to join the study.
  • Able and willing to follow study rules and complete all follow-up visits and tasks.

Who can't join

  • A major health condition that could affect the study or device, or a mental health or personality disorder that the study doctor decides rules you out.
  • An active bacterial infection that could spread to the blood, or an active C. difficile or CMV infection in the large intestine.
  • A hole in the large intestine, severe bowel swelling needing emergency surgery, or narrowing that blocks passage of a colonoscopy camera.
  • Other types of bowel swelling: swelling seen only under a microscope, caused by poor blood flow, or caused by infection.
  • An abnormal growth in the large intestine that has not been removed, or cancer currently in the digestive tract.
  • Past surgery for ulcerative colitis, or likely to need this surgery.
  • Currently in another clinical trial, previously had a nerve-stimulation device implanted, or previously joined a nerve-stimulation trial.
  • Unable to use the device's patient controller.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (19)

CA

KS

MN

MO

MS

NC

NV

NY

OH

PA

SC

SD

TX