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

Brief Title

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

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Number of participants with adverse events as a measurement of Safety

Secondary Outcome

 Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy

Condition

Tracheobronchomalacia

Intervention

Rigid bronchoscopy

Study Arms / Comparison Groups

 Stents
Description:  All recruited patients will be receiving a stent during a rigid bronchoscopy procedure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

110

Start Date

April 2011

Completion Date

June 2015

Primary Completion Date

April 2015

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amarilio V Macedo, Postdoc, 555133597872, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01389531

Organization ID

ORTESE 10-0515

Secondary IDs

ORTESE HCPA-1

Responsible Party

Sponsor

Study Sponsor

Hospital de Clinicas de Porto Alegre


Study Sponsor

Amarilio V Macedo, Postdoc, Principal Investigator, Hospital de Clinicas de Porto Alegre


Verification Date

December 2014