Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

NCT ID: NCT01153074

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchopleural Fistula

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Occluder

The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder.

Group Type EXPERIMENTAL

Closure of bronchopleural fistula with Occlutech Figulla

Intervention Type DEVICE

Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.

Interventions

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Closure of bronchopleural fistula with Occlutech Figulla

Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.

Intervention Type DEVICE

Other Intervention Names

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Bronchoscopic bronchopleural fistula closure with occluders

Eligibility Criteria

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Inclusion Criteria

* Patients over 14 years old
* Bronchopleural fistulas

Exclusion Criteria

* Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
* Immunosuppressed patients
* Acute intense inflammatory process in fistula edge
* Suppurative pleural cavity infection
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InCor Heart Institute

OTHER

Sponsor Role collaborator

Occlutech International AB

INDUSTRY

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Miguel L. Tedde

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel L. Tedde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor) HC of the Sao Paulo University School

Locations

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Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, , Brazil

Site Status

Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 21896530 (View on PubMed)

Tedde 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.

Reference Type RESULT
PMID: 21440188 (View on PubMed)

Scordamaglio 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.

Reference Type RESULT
PMID: 20011853 (View on PubMed)

Scordamaglio 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.

Reference Type RESULT
PMID: 28082466 (View on PubMed)

Other Identifiers

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USP01089/09-TBF

Identifier Type: -

Identifier Source: org_study_id

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