An early feasibility study to evaluate the safety and performance of sacral nerve stimulation in subjects with Crohn’s disease or ulcerative colitis

Eligibility Requirements

General Inclusion Criteria:

Male or female18 to 75 years of age

Disease duration of ≥ 6 months

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

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

History or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications

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

Active or latent tuberculosis

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

Principal Investigator

Ryan McConnell, M.D.

Co-Investigator(s)

Savitha Krishnan, MD