Clinical Trials Logo
  1. Home
  2. Lung Disease
  3. NCT01241617

ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections

Lung Disease Clinical Trial

Official title:
Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy

Clinical Trial Summary

The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.

Clinical Trial Description

Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.

Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.

Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01241617
Study type Interventional
Source Medtronic - MITG
Contact
Status Terminated
Phase N/A
Start date August 2010
Completion date January 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT02217423 - Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy N/A
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT01679301 - Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator N/A
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Terminated NCT00966823 - Fetal Tracheal Balloon Study in Diaphragmatic Hernia Phase 2
Completed NCT00139152 - Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair Phase 4
Completed NCT00052052 - An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Recruiting NCT02963467 - Effect of Smoking on Ventilation-Perfusion Ratio N/A
Recruiting NCT02965300 - The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis N/A
Enrolling by invitation NCT02946658 - Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders Phase 1/Phase 2
Recruiting NCT02913365 - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis N/A
Completed NCT01735526 - Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation N/A
Completed NCT01952002 - Clinical Safety for the Inspiratory Muscle Training N/A
Recruiting NCT01450644 - Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease Phase 2
Completed NCT01215279 - AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD) Phase 2
Completed NCT01153321 - Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Completed NCT00837681 - Pulmonary Complications of Hematopoietic Stem Cell Transplantation N/A
Completed NCT02055222 - Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
Completed NCT01222442 - To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart Phase 1