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

December 30, 2014 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20230130
        • Recruiting
        • Hospital do Cancer I
        • Contact:
        • Principal Investigator:
          • Mauro M Zamboni, Ms
      • Sao Paulo, Brazil, 05403000
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
        • Contact:
          • Helio Minamoto, Postdoc
          • Phone Number: 55 11 9977 5745
          • Email: minamoto@usp.br
        • Principal Investigator:
          • Helio Minamoto, Doctorate
      • Sao Paulo, Brazil, 04024002
        • Recruiting
        • Hospital Sao Paulo
        • Contact:
        • Principal Investigator:
          • Iunis Suzuki, Doctorate
    • Amazonas
      • Manaus, Amazonas, Brazil, 69010130
        • Recruiting
        • Hospital Universitário Getúlio Vargas
        • Contact:
        • Principal Investigator:
          • Fernando L Westphal, Doctorate
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70840901
        • Recruiting
        • Hospital Universitario de Brasilia
        • Contact:
        • Principal Investigator:
          • Nuno F Lima, Doctorate
    • Goias
      • Goiania, Goias, Brazil, 74605020
        • Recruiting
        • Hospital das Clinicas de Goiânia
        • Contact:
        • Principal Investigator:
          • Albino A Oliveira, MD
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59012300
        • Recruiting
        • Centro de Ciencias da Saude
        • Contact:
        • Principal Investigator:
          • Carlos A Araujo, Doctorate
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 900350903
        • Recruiting
        • HCPA Hospital de Clinicas de Porto Alegre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amarilio V Macedo, Postdoc
    • Rio de Janeiro
      • Niteroi, Rio de Janeiro, Brazil, 24322380
        • Recruiting
        • Hospital Universitario Antonio Pedro
        • Contact:
        • Principal Investigator:
          • Luiz F Judice, Doctorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a measurement of Safety
Time Frame: 1 year

three main adverse events will be followed:

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy
Time Frame: 1 year
MMRC dyspnea score will be used to measure the improvement of the patient's respiratory condition
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Amarilio V Macedo, Postdoc, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTESE 10-0515
  • ORTESE HCPA-1 (Other Grant/Funding Number: Ministerio da Saude/MS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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