Indication for Modification of Patient Physical Status
Conditions
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.
Interventions
DEVICEVela 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
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed