Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study

October 9, 2021 updated by: Miguel L. Tedde, University of Sao Paulo

Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study

Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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
      • Ribeirão Preto, Brazil
        • Recruiting
        • Hospital das Clinicas da USP Ribeirao
        • Contact:
        • Principal Investigator:
          • Tales R Nadai, MD, PhD
        • Sub-Investigator:
          • Caio CI Cirino, MD
    • SP
      • Botucatu, SP, Brazil
        • Recruiting
        • Hospital de Clinicas da Faculdade de Botucatu
        • Contact:
        • Principal Investigator:
          • Daniele C Cataneo, MD, PhD
      • Campinas, SP, Brazil
        • Recruiting
        • Hospital das Clínicas da UNICAMP
        • Contact:
        • Principal Investigator:
          • Ricardo K Mussi, MD, PhD
      • Sao Paulo, SP, Brazil
        • Recruiting
        • Instituto do Coração (InCor) HCFMUSP
        • Contact:
        • Principal Investigator:
          • Flavio H Savazzi, MD

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

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pectus carinatum condrogladiolar Variant
  • No other comorbidities that could interfere with the use of compressor

Exclusion Criteria:

  • Marfan Syndrome
  • Active cardiovascular disease
  • Significant scoliosis or thoracic deformity
  • Important obesity
  • Pectus carinatum chondromanubrial variant
  • Poor commitment to protocol by both research participant and parents

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: Bracing arm
Patients that will be using the thoracic compressor
Device: Thoracic compressor
The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficiency in repairing the pectus carinatum
Time Frame: 16 months
The anthroprometric measures in centimeters of the thoracic cage will be taken before and after the treatment to evaluate the effectiveness of the chest compressor in repairing the pectus carinatum
16 months
Treatment safety
Time Frame: 16 months
The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: 16 months
The number of hours of daily use of the chest compressor will be recorded as a measurement of the level of adherence to the chest compressor treatment
16 months
Device durability
Time Frame: 16 months
The mechanic problems presented by the chest compressor as fractures, screw loosening or fastener break will be recorded as a durability and strength measure of the chest compressor and its components.
16 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 Tedde, MD, PhD, Instituto do Coração (InCor) HCFMUSP

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 (Actual)

November 1, 2019

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USaoPauloGH (USaoPauloGH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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