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

Indication for Modification of Patient Physical Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02636738
• Other study ID #: E7110
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: September 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Indication for Modification of Patient Physical Status
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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