Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions.
Not Applicable
Recruiting
- Conditions
- Central airway stenosis
- Registration Number
- RBR-55jf6q
- Lead Sponsor
- Ministério da Saúde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Consent to participate in the study by signing (by the patient or family / legal guardian when aplicable) of the Informed Consent Form; 18 years old or more; clinically significant stenosis (symptomatic or about to become symptomatic) in the trachea, main bronchus or intermediate bronchus, which can be treated after a stente implant.
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).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety/adverse events. For the analysis of security-related measures will be assessed the number of subjects included in the clinical protocol that had the following adverse events during the period of 1 (one) year: migration of the stent, granuloma formation, accumulation of secretions. <br><br><br>
- Secondary Outcome Measures
Name Time Method Efficacy/Improvement of dyspnea.For analysis of measures of effectiveness, will assess the improvement of dyspnea in the research subjects included in the clinical protocol, using the MMRC dyspnea score to measure the improvement in the patient's respiratory status for a period of 1 (one) year.<br><br>