search
Back to results

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

Primary Purpose

Bronchopleural Fistula

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Closure of bronchopleural fistula with Occlutech Figulla
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopleural Fistula focused on measuring Bronchopleural fistula, Bronchoscopy

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Occluder

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2010
Last Updated
May 23, 2017
Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute, Occlutech International AB
search

1. Study Identification

Unique Protocol Identification Number
NCT01153074
Brief Title
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
Official Title
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute, Occlutech International AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopleural Fistula
Keywords
Bronchopleural fistula, Bronchoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occluder
Arm Type
Experimental
Arm Description
The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder.
Intervention Type
Device
Intervention Name(s)
Closure of bronchopleural fistula with Occlutech Figulla
Other Intervention Name(s)
Bronchoscopic bronchopleural fistula closure with occluders
Intervention Description
Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.
Primary Outcome Measure Information:
Title
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel L. Tedde, MD, PhD
Organizational Affiliation
Heart Institute (InCor) HC of the Sao Paulo University School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21896530
Citation
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.
Results Reference
result
PubMed Identifier
21440188
Citation
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.
Results Reference
result
PubMed Identifier
20011853
Citation
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.
Results Reference
result
PubMed Identifier
28082466
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs