Tracheobronchomalacia Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
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.
- It is a prospective multicenter clinical study, not controlled, with evaluation of
clinical variables before and after the intervention (insertion of one or more silicone
stents in the trachea or bronchi and main or intermediate bronchus by rigid
bronchoscopy under general anesthesia).
- 110 patients, both genders, will be followed for one year, total of 8 visits, in order
to evaluate the safety of the procedure of stent insertion.
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 allowed.
- The HCPA-1 silicone stent is made of biocompatible silicone, medical grade, via injection
process in the matrix using different densities of the same material for a set of prostheses
with rigid and flexible variables; available in the following dimensions (diameter x length
in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70.
Requires specific surgical (applicator) for insertion.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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