Bronchopleural FistulaNCT01153074
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
A study testing Closure of bronchopleural fistula with Occlutech Figulla in people with Bronchopleural Fistula, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bronchopleural Fistula
- What is being tested?
- Closure of bronchopleural fistula with Occlutech Figulla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2010to Oct 2016
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 14 years old
- Bronchopleural fistulas
Who cannot join
- Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
- Immunosuppressed patients
- Acute intense inflammatory process in fistula edge
- Suppurative pleural cavity infection
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, 05403-900
Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo
About this study
The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.
- Conditions
- Bronchopleural Fistula
- Being tested
- Closure of bronchopleural fistula with Occlutech Figulla
- Keywords
- Bronchopleural fistula, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of bronchopleural fistula with Occlutech FigullaDevice
Also called Bronchoscopic bronchopleural fistula closure with occluders
Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.
| Study group | Role | What they receive |
|---|---|---|
| Occluder | Experimental | The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder. Receives: Device: Closure of bronchopleural fistula with Occlutech Figulla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder
The closure of the fistulas will be bronchoscopically observed at regular intervals: one week, three weeks, two months and six months.
At the third months post intervention, a thorax CT scan will ascertain the correct position and stability of the device.
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 posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchopleural FistulaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Occlutech International AB
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Miguel L. Tedde, MD, PhD, Principal investigator, Heart Institute (InCor) HC of the Sao Paulo University School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153074
- Sponsor's protocol ID
- USP01089/09-TBF
- Status last verified
- May 2017
- First submitted
- 28 Jun 2010
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tedde ML, Scordamaglio PR, Rodrigues A, Minamoto H, Alfinito FS. Minimally invasive closure of bronchopleural fistulas. Chest. 2011 Sep;140(3):826. doi: 10.1378/chest.11-0719. No abstract available.
PubMed 21896530Tedde ML, Minamoto H, Scordamaglio PR, Rodrigues A, Moura EG, Pedra CA. Broncoscopic closure of tracheoesophageal fistulas. Ann Thorac Surg. 2011 Apr;91(4):1311. doi: 10.1016/j.athoracsur.2010.09.015. No abstract available.
PubMed 21440188Scordamaglio PR, Tedde ML, Minamoto H, Pedra CA, Jatene FB. Endoscopic treatment of tracheobronchial tree fistulas using atrial septal defect occluders: preliminary results. J Bras Pneumol. 2009 Nov;35(11):1156-60. doi: 10.1590/s1806-37132009001100015. English, Portuguese.
PubMed 20011853Scordamaglio PR, Tedde ML, Minamoto H, Assad RS, Fernandes PMP. Can total bronchopleural fistulas from complete stump dehiscence be endoscopically treated? Eur J Cardiothorac Surg. 2017 Apr 1;51(4):702-708. doi: 10.1093/ejcts/ezw377.
PubMed 28082466
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
- ClinicalTrials.gov ID
- NCT01153074
- Acronym / sponsor ID
- USP01089/09-TBF
- Conditions
- Bronchopleural Fistula
- Keywords
- Bronchopleural fistula, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Occlutech International AB
- Study start
- Jun 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jun 2010 (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 purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occluder | Experimental | Device: Closure of bronchopleural fistula with Occlutech FigullaThe patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 14 years old
- Bronchopleural fistulas
Key exclusion criteria (4 listed)
- Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
- Immunosuppressed patients
- Acute intense inflammatory process in fistula edge
- Suppurative pleural cavity infection
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 |
|---|---|---|
| Closure of bronchopleural fistula with Occlutech FigullaAlso: Bronchoscopic bronchopleural fistula closure with occludersPatients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject. | Device | Occluder |
Primary outcome
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder
Time frame: 1 year
The closure of the fistulas will be bronchoscopically observed at regular intervals: one week, three weeks, two months and six months. At the third months post intervention, a thorax CT scan will ascertain the correct position and stability of the device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results publication: PubMed 21896530Tedde ML, Scordamaglio PR, Rodrigues A, Minamoto H, Alfinito FS. Minimally invasive closure of bronchopleural fistulas. Chest. 2011 Sep;140(3):826. doi: 10.1378/chest.11-0719. No abstract available.
- Results publication: PubMed 21440188Tedde ML, Minamoto H, Scordamaglio PR, Rodrigues A, Moura EG, Pedra CA. Broncoscopic closure of tracheoesophageal fistulas. Ann Thorac Surg. 2011 Apr;91(4):1311. doi: 10.1016/j.athoracsur.2010.09.015. No abstract available.
- Results publication: PubMed 20011853Scordamaglio PR, Tedde ML, Minamoto H, Pedra CA, Jatene FB. Endoscopic treatment of tracheobronchial tree fistulas using atrial septal defect occluders: preliminary results. J Bras Pneumol. 2009 Nov;35(11):1156-60. doi: 10.1590/s1806-37132009001100015. English, Portuguese.
- Results publication: PubMed 28082466Scordamaglio PR, Tedde ML, Minamoto H, Assad RS, Fernandes PMP. Can total bronchopleural fistulas from complete stump dehiscence be endoscopically treated? Eur J Cardiothorac Surg. 2017 Apr 1;51(4):702-708. doi: 10.1093/ejcts/ezw377.
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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.
Miguel L. Tedde, MD, PhD principal investigator
Heart Institute (InCor) HC of the Sao Paulo University School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of bronchopleural fistula with Occlutech Figulla in people with Bronchopleural Fistula, run by University of Sao Paulo at 2 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 2 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: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder (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 NCT01153074, which also lists 4 linked publications.
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 25 May 2017.