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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Friendship Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experiment; Vela XL thulium laser, laser fiber and accessories	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technique success	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.	1 hour

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Shutian Zhang, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: E7110