Clinical trial · Observational
Powered Surgical Stapler in VATS Lung Resection Procedures in China
A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled. Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of prolonged air leaks
- timeFrame
- 30 days
Secondary outcomes (4)
- measure
- 2.Occurrence of postoperative air leaks
- timeFrame
- 30 days
- measure
- Length of stay (LOS)
- timeFrame
- 30 days
- measure
- Volume of estimated intra-operative blood loss
- timeFrame
- Intra-operative
- measure
- 5.Time to chest tube removal
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC); 2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 4. ASA score \< 3; 5. No prior history of VATS or open lung surgery; 6. Willing to give consent and comply with study-related evaluation and treatment schedule; and 7. At least 18 years of age. Exclusion Criteria: Subjects satisfying the following criteria will be eligible for participation in this study: 1. Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC); 2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 4. ASA score \< 3; 5. No prior history of VATS or open lung surgery; 6. Willing to give consent and comply with study-related evaluation and treatment schedule; and 7. At least 18 years of age.
References
Publications (0)
Data not yet available