Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT03241368
Eligibility Criteria:
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 (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information.
Exclusion Criteria:
* Subject has indeterminate, ulcerative, antibiotic-associated colitis.
* Subject has stool positive for ova and parasite and for Clostridium difficile 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.
* Subject with suspected or known bowel obstruction, stricture (defined as unequivocal proximal upstream dilation equal ≥ 2.5 cm), 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 discretion
* Subject with ileostomy or colostomy, history of total or subtotal colectomy (including those with ileosigmoidostomy, and ileorectostomy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03241368
Study Brief:
Protocol Section:
NCT03241368