Trial record 9 of 19 for:
Open Studies | "Cartilage Diseases"
Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
This study is currently recruiting participants.
Verified August 2011 by Hospital de Clinicas de Porto Alegre
Sponsor:
Hospital de Clinicas de Porto Alegre
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01389531
First received: June 17, 2011
Last updated: August 3, 2011
Last verified: August 2011
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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 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Stents |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389531
Locations
| Brazil | |
| Hospital Universitario Getulio Vargas | Recruiting |
| Manaus, Amazonas, Brazil, 69010130 | |
| Contact: Fernando L Westphal, Postdoc 55 92 3621 6500 f.l.westphal@uol.com.br | |
| Principal Investigator: Fernando L Westphal, Doctorate | |
| Hospital Universitario de Brasilia | Not yet recruiting |
| Brasilia, Distrito Federal, Brazil, 70840901 | |
| Contact: Nuno F Lima, Postdoc 55 61 9983 6304 nunolima@globo.com | |
| Principal Investigator: Nuno F Lima, Doctorate | |
| Hospital das Clínicas de Goiania | Not yet recruiting |
| Goiania, Goias, Brazil, 74605020 | |
| Contact: Albino A Oliveira, MD 55 62 99710224 aalegro@terra.com.br | |
| Principal Investigator: Albino A Oliveira, MD | |
| Hospital Universitario Antonio Pedro | Not yet recruiting |
| Niteroi, Rio de Janeiro, Brazil, 24322380 | |
| Contact: Luiz F Judice, Postdoc 55 21 9986 5267 lfjudice@urbi.com.br | |
| Principal Investigator: Luiz F Judice, Doctorate | |
| Centro de Ciencias da Saude | Not yet recruiting |
| Natal, Rio Grande do Norte, Brazil, 59012300 | |
| Contact: Carlos A Araujo, Doc 55 84 3125 4290 cabeto@digi.com.br | |
| Principal Investigator: Carlos A Araujo, Doctorate | |
| HCPA Hospital de Clinicas de Porto Alegre | Recruiting |
| Porto Alegre, Rio Grande do Sul, Brazil, 900350903 | |
| Contact: Amarilio V Macedo, `Postdoc 55 51 3359 8911 aneto@hcpa.ufrgs.br | |
| Contact: Rosane P Schlatter, Ms 55 51 3359 7872 rschlatter@hcpa.ufrgs.br | |
| Principal Investigator: Amarilio V Macedo, Postdoc | |
| Hospital Clementino Fraga Filho | Not yet recruiting |
| Rio de Janeiro, Brazil, 21941913 | |
| Contact: Giovanni A Marsico, Postdoc 55 21 9925 0170 marsicog@gbl.com.br | |
| Principal Investigator: Giovanni A Marsico, Doctorate | |
| Hospital do Cancer I | Not yet recruiting |
| Rio de Janeiro, Brazil, 20230130 | |
| Contact: Mauro M Zamboni, Postdoc 55 2506 6185 mauro.zamboni@gmail.com | |
| Principal Investigator: Mauro M Zamboni, Ms | |
| Hospital Sao Paulo | Not yet recruiting |
| Sao Paulo, Brazil, 04024002 | |
| Contact: Iunis Suzuki, Postdoc 55 11 8259 9455 iunis.suzuki@terra.com.br | |
| Principal Investigator: Iunis Suzuki, Doctorate | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | Not yet recruiting |
| Sao Paulo, Brazil, 05403000 | |
| Contact: Helio Minamoto, Postdoc 55 11 9977 5745 minamoto@usp.br | |
| Principal Investigator: Helio Minamoto, Doctorate | |
| Hospital A C Camargo | Not yet recruiting |
| Sao Paulo, Brazil, 01509190 | |
| Contact: Jefferson L Gross, Doctorate 55 11 2189 5020 jefluizgross@yahoo.com.br | |
| Principal Investigator: Jefferson L Gross, Doctorate | |
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
| Principal Investigator: | Amarilio V Macedo, Postdoc |
More Information
Publications:
| Responsible Party: | Amarilio Vieira de Macedo, Hospital de Clinicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT01389531 History of Changes |
| Other Study ID Numbers: | ORTESE, ORTESE HCPA-1 |
| Study First Received: | June 17, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Cartilage Diseases Airway Obstruction Tracheobronchomalacia Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |
Musculoskeletal Diseases Bronchial Diseases Tracheal Diseases Musculoskeletal Abnormalities Congenital Abnormalities Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013