Efficacy and Safety Evaluation of 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions|
- Number of participants with adverse events as a measurement of Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
three main adverse events will be followed:
- migration of the stent;
- granuloma formation;
- accumulation of secretion
- Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]MMRC dyspnea score will be used to measure the improvement of the patient's respiratory condition
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
All recruited patients will be receiving a stent during a rigid bronchoscopy procedure.
Procedure: Rigid bronchoscopy
The HCPA-1 silicone stent available in the following dimensions (diameter x length in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70 will be inserted through rigid bronchoscopy in patients who presented the criteria to participate in the study.
Other Name: stents
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389531
|Hospital Universitario Getulio Vargas|
|Manaus, Amazonas, Brazil, 69010130|
|Hospital Universitario de Brasilia|
|Brasilia, Distrito Federal, Brazil, 70840901|
|Hospital das Clínicas de Goiania|
|Goiania, Goias, Brazil, 74605020|
|Hospital Universitario Antonio Pedro|
|Niteroi, Rio de Janeiro, Brazil, 24322380|
|Centro de Ciencias da Saude|
|Natal, Rio Grande do Norte, Brazil, 59012300|
|HCPA Hospital de Clinicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil, 900350903|
|Hospital do Cancer I|
|Rio de Janeiro, Brazil, 20230130|
|Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo|
|Sao Paulo, Brazil, 05403000|
|Hospital Sao Paulo|
|Sao Paulo, Brazil, 04024002|
|Principal Investigator:||Amarilio V Macedo, Postdoc||Hospital de Clinicas de Porto Alegre|