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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03587532
Eligibility Criteria:
Inclusion Criteria:
Pre- and intraoperatively
* Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
* Subjects scheduled for elective minimally invasive Ivor Lewis esophagectomy
* Intrathoracic circular stapled esophago-gastric anastomosis
Exclusion Criteria:
Preoperatively
* Known hypersensitivity to ICG
* Female patients who are pregnant or nursing
* Participation in other studies involving investigational drugs or devices.
* Use of Avastin™ (bevacizumab) or other anti vascular endothelial growth factor (VEGF) agents within 30 days prior to surgery
Intra-operatively
* Intra-operative findings that may preclude conduct of the study procedures
* Anastomosis performed differently than the standard of care
* Excessive bleeding (\>500 ml) prior to anastomosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03587532
Study Brief:
Protocol Section:
NCT03587532