Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Tracheobronchomalacia

Treatments

Procedure: Rigid bronchoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01389531

ORTESE 10-0515

ORTESE HCPA-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.