Powered Echelon Device in VATS Surgery
A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
1 other identifier
observational
71
1 country
4
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
March 23, 2015
CompletedJune 18, 2015
March 1, 2015
1 year
April 19, 2013
March 6, 2015
May 21, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Occurrence of Postoperative Air Leaks
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).
Post-operative period through hospital discharge and follow-up at Day 30
Occurrence of Prolonged Air Leaks
Prolonged air leaks defined as longer than 5 days in continuous duration. 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).
Post-operative period through hospital discharge and follow-up at Day 30
Secondary Outcomes (6)
Length of Stay (LOS)
Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss
Blood loss intra-op and up to 5 days post-op
Time to Chest Tube Removal
Post-operative period through hospital discharge and follow-up at Day 30
Operative Time
Day of surgery
Occurrence of Intra-operative Leak Test
During surgery
- +1 more secondary outcomes
Study Arms (1)
VATS for suspected or confirmed NSCLC
Single arm study
Interventions
Eligibility Criteria
Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dignity Health, St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Schwiers
- Organization
- Ethicon, part of Johnson & Johnson
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2013
First Posted
April 30, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 18, 2015
Results First Posted
March 23, 2015
Record last verified: 2015-03