Powered Echelon Device in VATS Surgery

NCT01808430 | Completed DMC

• 1 other identifier: CME-12-001
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• occurrence and duration of post-operative air leak

  occurrence and duration of prolonged air leak defined as longer than 5 days

  prolonged air leak defined as longer than 5 days post-op

Secondary Outcomes (1)

• volume of estimated intra-operative blood loss

  blood loss intra-op and up to 5 days post-op

Study Arms (1)

VATS for NSCLC patients

VATS for confirmed non-small cell lung cancer (NSCLC)

Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)

Interventions

VATS for confirmed non-small cell lung cancer (NSCLC) PROCEDURE

Video-Assisted Thoracoscopic Surgery for NSCLC patients

Also known as: Video-Assisted Thoracoscopic Surgery

VATS for NSCLC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

You may qualify if:

• Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
• Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
• Willing to give consent and comply with evaluation and treatment schedule
• At least 18 years of age

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);
• Prior history of VATS or open lung surgery

Sponsors & Collaborators

• Ethicon Endo-Surgery (Europe) GmbH: lead

Study Sites (1)

Professor Peter Licht

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Goran Ribaric, MD, MSc, PhD

  Ethicon Endo-Surgery (Europe) GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 11, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

DK (1)