IBD
Conditions
Brief summary
Feasibility study of neuromodulation in patients with IBD.
Detailed description
The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.
Interventions
DEVICENeuromodulation
Neuromodulation
Sponsors
Boomerang Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Index | up to 1 year | CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis) |
Countries
United States
Outcome results
None listed