Research Studies

The CD subject must meet the following criteria: 1) Subject is diagnosed with Crohn’s disease, defined as: CDAI score ≥150 and ≤ 450, and/or a SES-CD score ≥3 2) Colorectal involvement (terminal ileitis may be present) UC-Specific Inclusion Criteria The UC subject must meet the following criteria: 1) Subject is diagnosed with ulcerative colitis, defined as: Total Mayo score ≥ 2, and/or endoscopy subscore of ≥ 1

CD-Specific Inclusion Criteria The CD subject must meet the following criteria: 1) Subject is diagnosed with Crohn’s disease, defined as: CDAI score ≥150 and ≤ 450, and/or a SES-CD score ≥3 2) Colorectal involvement (terminal ileitis may be present) UC-Specific Inclusion Criteria The UC subject must meet the following criteria: 1) Subject is diagnosed with ulcerative colitis, defined as: Total Mayo score ≥ 2, and/or endoscopy subscore of ≥ 1 In addition, the subject must meet ALL the following criteria: General Inclusion Criteria 1) Male or female 18 to 75 years of age 2) Naive of IBD drugs or stable on IBD drugs regimen 3) Ability and willingness to consent to participate by signing the informed consent form 4) Ability to comply with the protocol and willingness to comply with all follow-up requirements CD-Specific Exclusion Criteria The CD subject must not meet ANY of the following criteria: 1) Ulcerative or indeterminate colitis 2) Currently admitted to hospital for an acute flare related to inflammatory bowel disease UC-Specific Exclusion Criteria The UC subject must not meet ANY of the following criteria: 1) Crohn’s disease, indeterminate colitis 2) Currently admitted to hospital for an acute flare related to inflammatory bowel disease General Exclusion Criteria The subject must not meet ANY of the following criteria: 1) Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study 2) Any psychiatric or personality disorder at the discretion of the study Investigator 3) History or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drugs or prescription medications 4) Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) 5) Active clostridium difficile infection of the colon 6) Active cytomegalovirus (CMV) infection of the colon 7) Evidence of colonic perforation 8) Fulminant colitis requiring emergency surgery 9) Microscopic, ischemic or infectious colitis 10) Unresected neoplasia of the colon 11) Subjects who have undergone a proctocolectomy 12) Colonic stricture unable to pass a colonoscope 13) History of cancer including melanoma (except for localized skin cancers) within 2 years 14) Participation in another clinical trial within 30 days of device implant 15) Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant Device-Specific Exclusions: 16) A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception 17) Neurological diseases such as clinically significant peripheral neuropathy complete spinal cord injury (e.g. paraplegia) 18) Severe or uncontrolled diabetes or diabetes with peripheral nerve involvement (uncontrolled diabetes is defined as a documented HbA1C > 8% in the past 3 months) 19) History of pelvic irradiation with visible or functional effects of irradiation 20) Previously implanted with a neurostimulation device or participated in a neurostimulation trial (sacral or vagus) 21) Any device with known interaction with sacral nerve stimulation per the labeling 22) Passive implants with metal at the neurostimulator implant site 23) History of unilateral or bilateral vagotomy 24) Anatomical limitations preventing the successful placement of an electrode (e.g., spina bifida) 25) Subjects taking anticoagulant medications (e.g. warfarin, heparin) or antiplatelet agents (except aspirin) to reduce the risk of thromboembolic events or bleeding disorders 26) Documented history of allergic response to titanium, zirconia, polyurethane, epoxy or silicone 27) Knowledge of planned diathermy, microwave, lithotripsy or radiofrequency (RF) energy 28) Inability to operate the patient programmer