Boom-IBD Clinical Trial
Study Phase: N/A
Recruitment Status: Enrolling by invitation
Start Date: October 01, 2022
End Date: December 01, 2026
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