TracheobronchomalaciaNCT01389531
Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
A study testing Rigid bronchoscopy in people with Tracheobronchomalacia, run by Hospital de Clinicas de Porto Alegre at 9 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheobronchomalacia
- What is being tested?
- Rigid bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 9 sitesBrazil
- Study dates
- Apr 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites, 9 recruiting
- Recruiting
Hospital Universitario de Brasilia
Brasília, Federal District, 70840901
Nuno F Lima, Postdoc, 55 61 9983 6304, nunolima@globo.com
Nuno F Lima, Doctorate
- Recruiting
Hospital das Clínicas de Goiania
Goiânia, Goiás, 74605020
Albino A Oliveira, MD, 55 62 99710224, aalegro@terra.com.br
Albino A Oliveira, MD
- Recruiting
Hospital Universitario Getulio Vargas
Manaus, Amazonas, 69010130
Fernando L Westphal, Postdoc, 55 92 3621 6500, f.l.westphal@uol.com.br
Fernando L Westphal, Doctorate
- Recruiting
Centro de Ciencias da Saude
Natal, Rio Grande do Norte, 59012300
Carlos A Araujo, Doc, 55 84 3125 4290, cabeto@digi.com.br
Carlos A Araujo, Doctorate
- Recruiting
Hospital Universitario Antonio Pedro
Niterói, Rio de Janeiro, 24322380
Luiz F Judice, Postdoc, 55 21 9986 5267, lfjudice@urbi.com.br
Luiz F Judice, Doctorate
- Recruiting
HCPA Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 900350903
Amarilio V Macedo, 'Postdoc, 55 51 3359 8911, aneto@hcpa.ufrgs.br
Rosane P Schlatter, Ms, 55 51 3359 7872, rschlatter@hcpa.ufrgs.br
- Recruiting
Hospital do Cancer I
Rio de Janeiro, Rio de Janeiro, 20230130
Mauro M Zamboni, Postdoc, 55 2506 6185, mauro.zamboni@gmail.com
Mauro M Zamboni, Ms
- Recruiting
Hospital Sao Paulo
São Paulo, São Paulo, 04024002
Iunis Suzuki, Postdoc, 55 11 8259 9455, iunis.suzuki@terra.com.br
Iunis Suzuki, Doctorate
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403000
Helio Minamoto, Postdoc, 55 11 9977 5745, minamoto@usp.br
Helio Minamoto, Doctorate
About this study
Official title: 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.
Read the 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.
- Conditions
- Tracheobronchomalacia
- Being tested
- Rigid bronchoscopy
- Medical subject headings
- Tracheobronchomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid bronchoscopyProcedure or surgery
Also called stents
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.
| Study group | Role | What they receive |
|---|---|---|
| Stents | Other | All recruited patients will be receiving a stent during a rigid bronchoscopy procedure. Receives: Procedure: Rigid bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheobronchomalaciaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amarilio V Macedo, Postdoc, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389531
- Sponsor's protocol ID
- ORTESE 10-0515
- Other IDs
- ORTESE HCPA-1
- Status last verified
- Dec 2014
- First submitted
- 17 Jun 2011
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21149399
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
- ClinicalTrials.gov ID
- NCT01389531
- Acronym / sponsor ID
- ORTESE 10-0515
- Conditions
- Tracheobronchomalacia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stents | Other | Procedure: Rigid bronchoscopyAll recruited patients will be receiving a stent during a rigid bronchoscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rigid bronchoscopyAlso: stentsThe 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. | Procedure or surgery | Stents |
Primary outcome
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 secondary outcome
Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Background: PubMed 21149399Saueressig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amarilio V Macedo, Postdoc principal investigator
Hospital de Clinicas de Porto Alegre
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid bronchoscopy in people with Tracheobronchomalacia, run by Hospital de Clinicas de Porto Alegre at 9 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosane P Schlatter, Master (555133597872, rschlatter@hcpa.ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measurement of Safety (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.