Duet TRS Used in Pulmonary Resections

Not Applicable

Withdrawn

• Conditions: Lung Cancer
• Interventions: Device: Duet TRS

• Registration Number: NCT01026025
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duet TRS	Duet TRS	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
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.	intra-operative and 1 month follow up

Secondary Outcome Measures

Name	Time	Method
The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge.	discharge and 1 month follow up

Trial Locations

Locations (2)

Beth Israel Deaconess; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States