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

Not Applicable

Terminated

• Conditions: Indication for Modification of Patient Physical Status
• Interventions: Device: Vela XL thulium laser, laser fiber and accessories.

• Registration Number: NCT02636738
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Study Start: 2016-06-06
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experiment	Vela XL thulium laser, laser fiber and accessories.	Vela XL thulium laser, laser fiber and accessories

Primary Outcome Measures

Name	Time	Method
Technique success	1 hour	The procedure is mostly completed solely at one ESD procedure by VelaTM XL thulium laser, only if the direction of the laser could not be adjacent to the target, endoscopy knives will be assisted. The technique success rate will be calculated by the ratio of operation success subjects to total enrolled subjects.

Trial Locations

Locations (2)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China