Non-invasive Negative Pressure Treatment for Pectus Excavatum

University of Sao Paulo

Status: Completed

Conditions: Pectus Excavatum

Treatments: Device: Vacuum Bell

Study type: Interventional

Funder types: Other

Identifiers

NCT01816373

SDC 3591/11/009

2011/51156-5 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 8 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Vacuum Bell

Other group

Description:

Patients with pectus excavatum will be treated with the Vacuum Bell device

Treatment:

Device: Vacuum Bell