Duet TRS Used in Pulmonary Resections

NCT01026025 | Withdrawn

• 1 other identifier: AS09003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

lobectomy; segmentectomy; pulmonary resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Duet TRS

EXPERIMENTAL

This is a single arm study.

Device: Duet TRS

Interventions

Duet TRS DEVICE

This is a single arm study.

Duet TRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Beth Israel Deaconess

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hiran C Fernando, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

US (2)