Status:
COMPLETED
Non-invasive Negative Pressure Treatment for Pectus Excavatum
Lead Sponsor:
University of Sao Paulo
Conditions:
Pectus Excavatum
Eligibility:
All Genders
8-35 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment
Eligibility Criteria
Inclusion
- absence of co-morbidities that may interfere with proper placement or function of the apparatus
- test negative for pregnancy in women of childbearing age
Exclusion
- skeletal diseases like osteogenesis imperfecta or osteoporosis
- clotting disorders such as hemophilia or thrombopathia
- skin diseases or infections of the anterior chest wall
- angiopathies or vascular fragility
- obesity important with BMI greater than 30
- precarious commitment to the prolonged use of the device protocol
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01816373
Start Date
March 1 2013
End Date
October 1 2016
Last Update
May 25 2017
Active Locations (2)
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1
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil, 05403-000
2
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
São Paulo, Brazil, 05403900