MedTrace Logo

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

NCT04171063 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-12

No results posted yet for this study

Summary

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.

Conditions

  • Pectus Carinatum, Chondromanubrial

Interventions

DEVICE

Thoracic compressor

The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Miguel Tedde, MD, PhD · Instituto do Coracao (InCor) HCFMUSP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-06-01
Completion
2022-12-01

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171063 on ClinicalTrials.gov