Clinical trial · Interventional
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
NCT02636738CI-TRIAL-00040719terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): strategy change
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indication for Modification of Patient Physical Status | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vela XL thulium laser, laser fiber and accessories. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experiment
- description
- Vela XL thulium laser, laser fiber and accessories
- interventionNames
- Device: Vela XL thulium laser, laser fiber and accessories.
Primary outcomes (1)
- measure
- Technique success
- timeFrame
- 1 hour
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.