Non-invasive Negative Pressure Treatment for Pectus Excavatum

May 23, 2017 updated by: Miguel L. Tedde, University of Sao Paulo

Efficacy Evaluation of the 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • Sao Paulo, Brazil, 05403900
        • Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vacuum Bell
Patients with pectus excavatum will be treated with the Vacuum Bell device
Device: Vacuum Bell
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Miguel L. Tedde, MD, PhD, Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
  • Study Chair: Jose Ribas M de Campos, MD, PhD, Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 3591/11/009
  • 2011/51156-5 (Other Identifier: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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