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Duet TRS Used in Pulmonary Resections

This study has been withdrawn prior to enrollment.
(Sponsor is no longer pursuing this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026025
First Posted: December 4, 2009
Last Update Posted: August 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic - MITG
  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
Intervention Model: Single Group Assignment
Masking: None (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 Medtronic - MITG:

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026025


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

Responsible Party: Stephanie Marcucio, Senior Clinical Research Associate, Covidien
ClinicalTrials.gov Identifier: NCT01026025     History of Changes
Other Study ID Numbers: AS09003
First Submitted: December 3, 2009
First Posted: December 4, 2009
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Medtronic - MITG:
lobectomy
segmentectomy
pulmonary resection