Duet TRS Used in Pulmonary Resections

Medtronic

Status: Withdrawn

Conditions: Lung Cancer

Treatments: Device: Duet TRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026025

AS09003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Duet TRS

Experimental group

Description:

This is a single arm study.

Treatment:

Device: Duet TRS