strategy change

Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow up for evaluate the safety and utility of VelaTM XL thulium laser.

This study aimed to evaluate the safety and utility of VelaTM XL thulium laser in cutting and hemostasis for gastrointestinal epithelial neoplasia in Chinese population.

Vela China study will enroll at least 60 patients. Follow up points are 72 ±3 hours post procedure, 7±2 days post procedure, 14 days(±2 days) post procedure.

Inclusion Criteria:

• Willing and able to provide written informed consent to participate in the study and comply with the study procedures.
• Diagnosed as gastrointestinal epithelial neoplasia and admitted to hospital for gastrointestinal ESD procedure.
• EUS and/or CT are performed to confirm the absence of regional lymph node or distant metastasis.

Exclusion Criteria:

• Endoscopic techniques or treatment are contraindicated.
• Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
• Based on doctor's evaluation, the patient's medical condition doesn't fit for this study.