Non-invasive Negative Pressure Treatment for Pectus Excavatum
Not Applicable
Completed
- Conditions
- Pectus Excavatum
- Interventions
- Device: Vacuum Bell
- Registration Number
- NCT01816373
- Lead Sponsor
- University of Sao Paulo
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- absence of co-morbidities that may interfere with proper placement or function of the apparatus
- test negative for pregnancy in women of childbearing age
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vacuum Bell Vacuum Bell Patients with pectus excavatum will be treated with the Vacuum Bell device
- Primary Outcome Measures
Name Time Method Measurement of the reduction in the deepness of the pectus excavatum 3 months The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study
- Secondary Outcome Measures
Name Time Method Evaluation of quality of life related to self-esteem One year The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device
Trial Locations
- Locations (2)
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
🇧🇷Sao Paulo, Brazil