Non-invasive Negative Pressure Treatment for Pectus Excavatum

University of Sao Paulo30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pectus Excavatum

Interventions

Vacuum BellDEVICE

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, Brazil

Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP

São Paulo, Brazil

Outcomes

Primary Outcomes

Measurement of the reduction in the deepness of the pectus excavatum

The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study

Time frame: 3 months

Secondary Outcomes

Evaluation of quality of life related to self-esteem

The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device

Time frame: One year

Data from ClinicalTrials.gov

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