Vela China Study: in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population

Boston Scientific

Status: Terminated

Conditions: Indication for Modification of Patient Physical Status

Treatments: Device: Vela XL thulium laser, laser fiber and accessories.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636738

E7110

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

experiment

Experimental group

Description:

Vela XL thulium laser, laser fiber and accessories

Treatment:

Device: Vela XL thulium laser, laser fiber and accessories.