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Completed

NCT Number: NCT02338583

Powered Surgical Stapler in VATS Lung Resection Procedures in China

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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; and
  • At least 18 years of age.

Exclusion criteria

Subjects satisfying the following criteria will be eligible for participation in this study:

  • 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);
  • 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; and
  • At least 18 years of age.

Treatment and study plan

Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter

Device

Primary outcomes

  1. Occurrence of prolonged air leaks

    Time frame: 30 days

Secondary outcomes

  1. 2.Occurrence of postoperative air leaks

    Time frame: 30 days

  2. Length of stay (LOS)

    Time frame: 30 days

  3. Volume of estimated intra-operative blood loss

    Time frame: Intra-operative

  4. 5.Time to chest tube removal

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2015
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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