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

May 23, 2017 updated by: Miguel L. Tedde, University of Sao Paulo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
      • Sao Paulo, Brazil
        • Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occluder
The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder.
Device: 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.
Other Names:
  • Bronchoscopic bronchopleural fistula closure with occluders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

InCor Heart Institute
Occlutech International AB

Investigators

  • Principal Investigator: Miguel L. Tedde, MD, PhD, Heart Institute (InCor) HC of the Sao Paulo University School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP01089/09-TBF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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