Clinical trial · Observational
Powered Echelon Device in VATS Surgery
A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
NCT01843192CI-TRIAL-00018290completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).
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 (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocutter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- VATS for suspected or confirmed NSCLC
- description
- Single arm study
- interventionNames
- Device: Endocutter
Primary outcomes (2)
- measure
- Occurrence of Postoperative Air Leaks
- timeFrame
- Post-operative period through hospital discharge and follow-up at Day 30
- description
- Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
- measure
- Occurrence of Prolonged Air Leaks
- timeFrame
- Post-operative period through hospital discharge and follow-up at Day 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected or confirmed NSCLC (up to and including Stage II) * Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung * Performance status 0-1 (Eastern Cooperative Oncology Group classification) * ASA score \< 3 * No prior history of VATS or open lung surgery * Willing to give consent and comply with study-related evaluation and treatment schedule Exclusion Criteria: * Active bacterial infection or fungal infection; * Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure) * Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure * Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed) * Pregnancy * Physical or psychological condition which would impair study participation; * The patient is judged unsuitable for study participation by the Investigator for any other reason; or * Unable or unwilling to attend follow-up visits and examinations
References
Publications (0)
Data not yet available
No reference posted for this study.