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The study was terminated because the rate of prothesis dislocation was too high.
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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
| W.L.Gore & Associates | INDUSTRY |
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Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fistula closure with occluder | Experimental | Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fistula closure with Gore Helex Septal Occluder | Device | The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder | The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder. A thorax CT scan will ascertain correct positioning and stability of the occluder. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel L Tedde, MD, PhD | Heart Institute (InCor)-HC of the Sao Paulo University Medica School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School | São Paulo | São Paulo | 05403-900 | Brazil |
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| ID | Term |
|---|---|
| D055989 | Septal Occluder Device |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Gore Helex Septal Occluder | Device | Fistula closure with endoscopic release of occluder in the fistula traject. |
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