TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage

The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.

Inclusion Criteria:

• Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.