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

Tracheobronchomalacia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01389531
• Other study ID #: ORTESE 10-0515
• Secondary ID: ORTESE HCPA-1
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2011
• Last updated: December 30, 2014
• Start date: April 2011
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rosane P Schlatter, Master
• Phone: 555133597872
• Email: rschlatter[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Airway Obstruction
• Tracheobronchomalacia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitario de Brasilia	Brasilia	Distrito Federal
Brazil	Hospital das Clínicas de Goiania	Goiania	Goias
Brazil	Hospital Universitario Getulio Vargas	Manaus	Amazonas
Brazil	Centro de Ciencias da Saude	Natal	Rio Grande do Norte
Brazil	Hospital Universitario Antonio Pedro	Niteroi	Rio de Janeiro
Brazil	HCPA Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital do Cancer I	Rio de Janeiro
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Brazil	Hospital Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measurement of Safety	three main adverse events will be followed: migration of the stent; granuloma formation; accumulation of secretion	1 year	Yes
Secondary	Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy	MMRC dyspnea score will be used to measure the improvement of the patient's respiratory condition	1 year	Yes