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

Boston Scientific Corporation2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Indication for Modification of Patient Physical Status

Interventions

Vela XL thulium laser, laser fiber and accessories.DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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