Non-invasive Negative Pressure Treatment for Pectus Excavatum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pectus Excavatum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vacuum Bell

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

Group Type OTHER

Vacuum Bell

Intervention Type DEVICE

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

Interventions

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Vacuum Bell

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes