Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstru… (NCT01389531) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
Brazil110 participantsStarted 2011-04
Plain-language summary
The aim of the study is, primarily, evaluate the safety of the use of the silicone stent HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis. Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent HCPA-1 who are in the same conditions described above and also estimate the costs the use of these silicone stents involve.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Consent to participate in the study by signing (the patient or family member/ legal guardian) of the Informed Consent Form;
* 18 years old or more;
* clinically significant stenosis (symptomatic or about to become symptomatic) for the trachea, main bronchus or intermediate bronchus, which can be treated with the stent implement.
Exclusion Criteria:
* clinical or absolute anesthesic contraindication of the rigid bronchoscopy under general anesthesia;
* constitutional or acquired anatomic limitations that prevent the rigid bronchoscopy;
* another indication of exclusive preferential treatment modality for stenosis (surgery, radiotherapy, chemotherapy, other). Note: It is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement);
* full anticoagulation or severe disturbance of coagulation. (Includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with INR\> 2.0 or aPTT \[KTTP\]\> 1.5 times control or platelet count \<50000). Note: The use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is permitted.
What they're measuring
1
Number of participants with adverse events as a measurement of Safety