Phase
Condition
Inflammatory Bowel Disease
Treatment
Neuromodulation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Reliance Research
Scottsdale, Arizona 85260
United StatesSite Not Available
Phillip Fleshner, Inc.
Los Angeles, California 90048
United StatesSite Not Available
Palo Alto Medical Foundation Research Institute
Palo Alto, California 94301
United StatesSite Not Available
CU Anschutz
Aurora, Colorado 80045
United StatesSite Not Available
Kansas Gastroenterology
Wichita, Kansas 67226-8119
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
The Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Colon Surgeons of Charleston
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
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