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Completed

NCT Number: NCT01816373

Non-invasive Negative Pressure Treatment for Pectus Excavatum

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

Completed

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

8 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vacuum Bell

Device

Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device

Primary outcomes

  1. Measurement of the reduction in the deepness of the pectus excavatum

    Time frame: 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 outcomes

  1. Evaluation of quality of life related to self-esteem

    Time frame: 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

Other outcomes

  1. Evaluate the safety and adherence to the treatment

    Time frame: three months

    The patients will be followed to assure adherence and safety of the treatment

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 22, 2013
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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