Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
NCT ID: NCT01389531
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2011-04-30
2015-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Stents
All recruited patients will be receiving a stent during a rigid bronchoscopy 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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Amarilio V Macedo, Postdoc
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas de Porto Alegre
Locations
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Hospital Universitario Getulio Vargas
Manaus, Amazonas, Brazil
Hospital Universitario de Brasilia
Brasília, Federal District, Brazil
Hospital das Clínicas de Goiania
Goiânia, Goiás, Brazil
Hospital Universitario Antonio Pedro
Niterói, Rio de Janeiro, Brazil
Hospital do Cancer I
Rio de Janeiro, Rio de Janeiro, Brazil
Centro de Ciencias da Saude
Natal, Rio Grande do Norte, Brazil
HCPA Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Fernando L Westphal, Postdoc
Role: primary
Nuno F Lima, Postdoc
Role: primary
Albino A Oliveira, MD
Role: primary
Luiz F Judice, Postdoc
Role: primary
Mauro M Zamboni, Postdoc
Role: primary
Carlos A Araujo, Doc
Role: primary
Amarilio V Macedo, 'Postdoc
Role: primary
Rosane P Schlatter, Ms
Role: backup
Iunis Suzuki, Postdoc
Role: primary
Helio Minamoto, Postdoc
Role: primary
References
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Saueressig MG, Sanches PR, Macedo Neto AV, Moreschi AH, Oliveira HG, Xavier RG. Novel silicone stent to treat tracheobronchial lesions: results of 35 patients. Asian Cardiovasc Thorac Ann. 2010 Dec;18(6):521-8. doi: 10.1177/0218492310388428.
Other Identifiers
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ORTESE HCPA-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ORTESE 10-0515
Identifier Type: -
Identifier Source: org_study_id