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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT04578392
Eligibility Criteria:
Inclusion Criteria:
* Males and females 18-65 years of age.
* Isolated ileocolic Crohn's disease of \<30 cm in length
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
* Ability to comply with protocol
* Competent and able to provide written informed consent
* Medically refractory disease or inability to tolerate ongoing medical therapy
Exclusion Criteria:Inability to give informed consent.
* Patients less than 18 years of age
* Patients undergoing repeat ileocolic resection
* Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection.
* Patients with \>30 cm of terminal ileal disease
* Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
* Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
* Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* Specific exclusions; Evidence of hepatitis B, C, or HIV
* History of cancer including melanoma (with the exception of localized skin cancers)
* Emergent indication for an operation
* Pregnant or breast feeding.
* History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
* Inability to follow up at respective sites for the primary endpoint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04578392
Study Brief:
Protocol Section:
NCT04578392