This trial is active, not recruiting.

Condition pectus excavatum
Treatment vacuum bell
Sponsor University of Sao Paulo
Start date March 2013
End date April 2014
Trial size 30 participants
Trial identifier NCT01816373, 2011/51156-5, SDC 3591/11/009


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients with pectus excavatum will be treated with the Vacuum Bell device
vacuum bell
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device

Primary Outcomes

Measurement of the reduction in the deepness of the pectus excavatum
time frame: 3 months

Secondary Outcomes

Evaluation of quality of life related to self-esteem
time frame: One year

Eligibility Criteria

Male or female participants from 8 years up to 35 years old.

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

Additional Information

Official title Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
Principal investigator Miguel L. Tedde, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo.