Duet TRS Used in Pulmonary Resections

This study has been withdrawn prior to enrollment.
(Sponsor is no longer pursuing this study)
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT01026025
First received: December 3, 2009
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.


Condition Intervention
Lung Cancer
Device: Duet TRS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Evaluation of Endo GIA Staplers With Endo GIA Single Use Loading Units (SULUs) With Duet TRS TM in a Pulmonary Resection

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • The primary objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days)in an anatomic pulmonary resection. [ Time Frame: intra-operative and 1 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge. [ Time Frame: discharge and 1 month follow up ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duet TRS
This is a single arm study.
Device: Duet TRS
This is a single arm study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patient must be 18 years of age or older
  • The patient must be scheduled to undergo segmentectomy or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer
  • The patient must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure
  • The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

  • The patient is pregnant or breastfeeding
  • The patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease
  • The patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected
  • The patient is scheduled to receive intra-operative brachytherapy
  • The patient has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months
  • Re-operative surgery is excluded if it is on the same side as the previous surgery
  • The patient requires chest wall reconstruction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026025

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Hiran C Fernando, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: Stephanie Marcucio, Senior Clinical Research Associate, Covidien
ClinicalTrials.gov Identifier: NCT01026025     History of Changes
Other Study ID Numbers: AS09003
Study First Received: December 3, 2009
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
lobectomy
segmentectomy
pulmonary resection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014