Clinical Trials

Inclusion Criteria:

• Subject has provided informed consent.
• Subject is ≥ 18 years of age
• Subject is willing and able to comply with all aspects of treatment and evaluation schedule.
• Subject has known CD and a recent history (within last 2 years) of mucosal disease (diagnosis based on radiologic, endoscopic, or histological evidence).

Exclusion Criteria:

• Subject has indeterminate, ulcerative, antibiotic-associated colitis.
• Subject has stool positive for ova and parasite and for Clostridium difficule toxins within 3 months prior to enrollment.
• Subject with other known infectious cause of abdominal symptoms.
• Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range.
• Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
• Subjects with a history of small bowel or colonic resection.
• Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
• Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (< 100 mg daily) are acceptable and not exclusionary.
• Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions.
• Subject with cardiac pacemaker or other implanted electromedical device.
• Subject has an allergy or other known contraindication to the medications used in the study.
• Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
• Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity).
• Subject has a known contraindication to MRE or IC.
• Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study.
• Subject has any medical condition that would make it unsafe for them to participate, per Investigator's descretion