Boom-IBD Clinical Trial

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

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