Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
2 other identifiers
interventional
110
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 31, 2014
December 1, 2014
4 years
June 17, 2011
December 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy
1 year
Study Arms (1)
Stents
OTHERAll recruited patients will be receiving a stent during a rigid bronchoscopy procedure.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Consent to participate in the study by signing (the patient or family member/ legal guardian) of the Informed Consent Form;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Hospital Universitario Getulio Vargas
Manaus, Amazonas, 69010130, Brazil
Hospital Universitario de Brasilia
Brasília, Federal District, 70840901, Brazil
Hospital das Clínicas de Goiania
Goiânia, Goiás, 74605020, Brazil
Hospital Universitario Antonio Pedro
Niterói, Rio de Janeiro, 24322380, Brazil
Hospital do Cancer I
Rio de Janeiro, Rio de Janeiro, 20230130, Brazil
Centro de Ciencias da Saude
Natal, Rio Grande do Norte, 59012300, Brazil
HCPA Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 900350903, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, 04024002, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403000, Brazil
Related 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.
PMID: 21149399BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amarilio V Macedo, Postdoc
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2011
First Posted
July 8, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
December 31, 2014
Record last verified: 2014-12