BOOM-IBD2 Pivotal Clinical Trial

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 consentform

• Ability to comply with the protocol and willingness to comply with all follow uprequirements

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 ofabscess)

• 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 suchintervention

• Previously implanted with a neurostimulation device or participated in aneurostimulation trial

• Inability to operate the patient programmer