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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01389531
First received: June 17, 2011
Last updated: November 11, 2014
Last verified: November 2014
  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 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stents
All recruited patients will be receiving a stent during a rigid bronchoscopy procedure.
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
Manaus, Amazonas, Brazil, 69010130
Hospital Universitario de Brasilia
Brasilia, Distrito Federal, Brazil, 70840901
Hospital das Clínicas de Goiania
Goiania, Goias, Brazil, 74605020
Hospital Universitario Antonio Pedro
Niteroi, Rio de Janeiro, Brazil, 24322380
Centro de Ciencias da Saude
Natal, Rio Grande do Norte, Brazil, 59012300
HCPA Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 900350903
Hospital do Cancer I
Rio de Janeiro, Brazil, 20230130
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 05403000
Hospital Sao Paulo
Sao Paulo, Brazil, 04024002
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Amarilio V Macedo, Postdoc Hospital de Clinicas de Porto Alegre
  More Information

Publications:
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01389531     History of Changes
Other Study ID Numbers: ORTESE 10-0515, ORTESE HCPA-1
Study First Received: June 17, 2011
Last Updated: November 11, 2014
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on November 20, 2014