Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
18 Years
N/A
Both
Tracheobronchomalacia
Trial Information
Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
- 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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Number of participants with adverse events as a measurement of Safety
Outcome Description:
three main adverse events will be followed: migration of the stent; granuloma formation; accumulation of secretion
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Amarilio V Macedo, Postdoc
Investigator Role:
Principal Investigator
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
ORTESE
NCT ID:
NCT01389531
Start Date:
April 2011
Completion Date:
June 2013
Related Keywords:
- Tracheobronchomalacia
- Airway Obstruction
- Tracheobronchomalacia
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