NCT02636738

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

A Prospective, Multicenter, Single-arm, Non-controlled Study to Evaluate The Safety and Utility of VelaTM XL Thulium Laser in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Indication for Modification of Patient Physical Status

Interventions

Type	Name	Description
DEVICE	Vela XL thulium laser, laser fiber and accessories.	The VelaTM XL Laser is a continuous wave thulium laser that uses an optimized 1.94μm wavelength. This powerful, highly precise laser is designed for hemostatic cutting or ablation of soft and hard tissue

Timeline

• Start date: 2016-06-06
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2015-12-22
• Last updated: 2019-09-20

Locations

2 sites across 1 country: China