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se of the fluorecent dye indocyanine green for the evaluation of theblood flow in the wind pipe after surgery

Phase 1
Conditions
Tracheal stenosis secondary to malign and benign conditions
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Registration Number
EUCTR2013-001725-10-AT
Lead Sponsor
Medizinische Universität Wien
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

• age >18
• written informed consent
• elective tracheal resection at the Division of Thoracic Surgery,
Medical University of Vienna
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

• age >80
• participation in other clinical studies
• pregnancy
• renal or hepatic failure
• previous tracheal surgery
• previous reactions to ICG or iodide
• hyper-/hypothyroidism
• active hematological disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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