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:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT02105506
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis
* Male and female gender
* Ages 18-80
* Signed informed consent
* For females of childbearing potential:
* Patient uses a reliable contraceptive method: contraceptive pill, intrauterine device, subdermal implantation, or transdermal patch
* Patient has a negative serum or urine pregnancy test.
Exclusion Criteria:
* Emergency resections of esophagus of stomach
* Unsigned informed consent
* History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.
* Patients having difficulty understanding Dutch and English
* Mentally incapable patients
* Pregnancy or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02105506
Study Brief:
Protocol Section:
NCT02105506