Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
- Conditions
- Tracheobronchomalacia
- Interventions
- Procedure: Rigid bronchoscopy
- Registration Number
- NCT01389531
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief 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.
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stents Rigid bronchoscopy All recruited patients will be receiving a stent during a rigid bronchoscopy procedure.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measurement of Safety 1 year three main adverse events will be followed:
* migration of the stent;
* granuloma formation;
* accumulation of secretion
- Secondary Outcome Measures
Name Time Method Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy 1 year MMRC dyspnea score will be used to measure the improvement of the patient's respiratory condition
Trial Locations
- Locations (9)
Hospital Universitario Getulio Vargas
🇧🇷Manaus, Amazonas, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Centro de Ciencias da Saude
🇧🇷Natal, Rio Grande do Norte, Brazil
Hospital Universitario de Brasilia
🇧🇷Brasilia, Distrito Federal, Brazil
Hospital Universitario Antonio Pedro
🇧🇷Niteroi, Rio de Janeiro, Brazil
Hospital das ClÃnicas de Goiania
🇧🇷Goiania, Goias, Brazil
HCPA Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Hospital do Cancer I
🇧🇷Rio de Janeiro, Brazil
Hospital Sao Paulo
🇧🇷Sao Paulo, Brazil