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

NCT00293514 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Diseases
  • Intraoperative Complications

Interventions

DRUG

Fibrinogen (human) + thrombin (human) (TachoSil)

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquarters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293514 on ClinicalTrials.gov