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

NCT ID: NCT00293514

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Diseases Intraoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nycomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinical Trial Operations

Principal Investigators

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Nycomed Clinical Trial Operations

Role: STUDY_CHAIR

Headquarters

Locations

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Nycomed

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2004-002380-24

Identifier Type: -

Identifier Source: secondary_id

TC-021-IM

Identifier Type: -

Identifier Source: org_study_id

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