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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01389531
First received: June 17, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Tracheobronchomalacia
Procedure: Rigid bronchoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Number of participants with adverse events as a measurement of Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    three main adverse events will be followed:

    • migration of the stent;
    • granuloma formation;
    • accumulation of secretion


Secondary Outcome Measures:
  • Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    MMRC dyspnea score will be used to measure the improvement of the patient's respiratory condition


Estimated Enrollment: 110
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stents 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.
Other Name: stents

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389531

Locations
Brazil
Hospital Universitario Getulio Vargas Recruiting
Manaus, Amazonas, Brazil, 69010130
Contact: Fernando L Westphal, Postdoc    55 92 3621 6500    f.l.westphal@uol.com.br   
Principal Investigator: Fernando L Westphal, Doctorate         
Hospital Universitario de Brasilia Not yet recruiting
Brasilia, Distrito Federal, Brazil, 70840901
Contact: Nuno F Lima, Postdoc    55 61 9983 6304    nunolima@globo.com   
Principal Investigator: Nuno F Lima, Doctorate         
Hospital das Clínicas de Goiania Not yet recruiting
Goiania, Goias, Brazil, 74605020
Contact: Albino A Oliveira, MD    55 62 99710224    aalegro@terra.com.br   
Principal Investigator: Albino A Oliveira, MD         
Hospital Universitario Antonio Pedro Not yet recruiting
Niteroi, Rio de Janeiro, Brazil, 24322380
Contact: Luiz F Judice, Postdoc    55 21 9986 5267    lfjudice@urbi.com.br   
Principal Investigator: Luiz F Judice, Doctorate         
Centro de Ciencias da Saude Not yet recruiting
Natal, Rio Grande do Norte, Brazil, 59012300
Contact: Carlos A Araujo, Doc    55 84 3125 4290    cabeto@digi.com.br   
Principal Investigator: Carlos A Araujo, Doctorate         
HCPA Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 900350903
Contact: Amarilio V Macedo, `Postdoc    55 51 3359 8911    aneto@hcpa.ufrgs.br   
Contact: Rosane P Schlatter, Ms    55 51 3359 7872    rschlatter@hcpa.ufrgs.br   
Principal Investigator: Amarilio V Macedo, Postdoc         
Hospital Clementino Fraga Filho Not yet recruiting
Rio de Janeiro, Brazil, 21941913
Contact: Giovanni A Marsico, Postdoc    55 21 9925 0170    marsicog@gbl.com.br   
Principal Investigator: Giovanni A Marsico, Doctorate         
Hospital do Cancer I Not yet recruiting
Rio de Janeiro, Brazil, 20230130
Contact: Mauro M Zamboni, Postdoc    55 2506 6185    mauro.zamboni@gmail.com   
Principal Investigator: Mauro M Zamboni, Ms         
Hospital Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 04024002
Contact: Iunis Suzuki, Postdoc    55 11 8259 9455    iunis.suzuki@terra.com.br   
Principal Investigator: Iunis Suzuki, Doctorate         
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 05403000
Contact: Helio Minamoto, Postdoc    55 11 9977 5745    minamoto@usp.br   
Principal Investigator: Helio Minamoto, Doctorate         
Hospital A C Camargo Not yet recruiting
Sao Paulo, Brazil, 01509190
Contact: Jefferson L Gross, Doctorate    55 11 2189 5020    jefluizgross@yahoo.com.br   
Principal Investigator: Jefferson L Gross, Doctorate         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Amarilio V Macedo, Postdoc
  More Information

Publications:
Responsible Party: Amarilio Vieira de Macedo, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01389531     History of Changes
Other Study ID Numbers: ORTESE, ORTESE HCPA-1
Study First Received: June 17, 2011
Last Updated: August 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Airway Obstruction
Tracheobronchomalacia
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 20, 2014