Completed

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

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What is being tested

Vacuum Bell

Device
Who is being recruted

Bone Diseases+4

+ Bone Diseases, Developmental

+ Musculoskeletal Abnormalities

From 8 to 35 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: May 25, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01816373
Principal SponsorUniversity of Sao Paulo
Last updated: May 25, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCongenital AbnormalitiesFunnel Chest

Criteria

2 inclusion criteria required to participate
absence of co-morbidities that may interfere with proper placement or function of the apparatus
test negative for pregnancy in women of childbearing age
6 exclusion criteria prevent from participating
angiopathies or vascular fragility
clotting disorders such as hemophilia or thrombopathia
obesity important with BMI greater than 30
precarious commitment to the prolonged use of the device protocol
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

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

São Paulo, BrazilOpen Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo in Google Maps

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

São Paulo, Brazil
Completed2 Study Centers