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

Primary Purpose

Pectus Carinatum, Chondromanubrial

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Thoracic compressor
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Carinatum, Chondromanubrial focused on measuring Braces, Conservative treatment, Thoracic wall, Pectus carinatum

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clinicas da Faculdade de BotucatuRecruiting
  • Hospital das Clinicas da UnicampRecruiting
  • Instituto do Coracao (InCor) HCFMUSPRecruiting
  • Hospital das Clinicas da USP RibeiraoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bracing arm

Arm Description

Patients that will be using the thoracic compressor

Outcomes

Primary Outcome Measures

Treatment efficiency in repairing the pectus carinatum
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
Treatment safety
The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair

Secondary Outcome Measures

Treatment adherence
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
Device durability
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.

Full Information

First Posted
November 7, 2019
Last Updated
October 9, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04171063
Brief Title
Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study
Official Title
Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Carinatum, Chondromanubrial
Keywords
Braces, Conservative treatment, Thoracic wall, Pectus carinatum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will be allocated to use the thoracic compressor for 16 months
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bracing arm
Arm Type
Other
Arm Description
Patients that will be using the thoracic compressor
Intervention Type
Device
Intervention Name(s)
Thoracic compressor
Intervention Description
The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum
Primary Outcome Measure Information:
Title
Treatment efficiency in repairing the pectus carinatum
Description
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
Time Frame
16 months
Title
Treatment safety
Description
The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Treatment adherence
Description
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
Time Frame
16 months
Title
Device durability
Description
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.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Tedde, MD, PhD
Organizational Affiliation
Instituto do Coracao (InCor) HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas da Faculdade de Botucatu
City
Botucatu
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Cataneo
Phone
+55(14) 3880-1529
Email
dcataneo@fmb.unesp.br
First Name & Middle Initial & Last Name & Degree
Daniele C Cataneo, MD, PhD
Facility Name
Hospital das Clinicas da Unicamp
City
Campinas
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo K Mussi
Phone
+55 (19) 3521-9450
Email
rkalaf@fcm.unicamp.br
First Name & Middle Initial & Last Name & Degree
Ricardo K Mussi, MD, PhD
Facility Name
Instituto do Coracao (InCor) HCFMUSP
City
Sao Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Savazzi
Phone
+55(11) 2661-5708
Email
carinatum.incor@gmail.com
First Name & Middle Initial & Last Name & Degree
Flavio H Savazzi, MD
Facility Name
Hospital das Clinicas da USP Ribeirao
City
Ribeirão Preto
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tales R Nadai
Phone
+55 (16) 3393-7865
Email
talesusp@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Tales R Nadai, MD, PhD
First Name & Middle Initial & Last Name & Degree
Caio CI Cirino, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16080931
Citation
Kelly RE Jr, Lawson ML, Paidas CN, Hruban RH. Pectus excavatum in a 112-year autopsy series: anatomic findings and the effect on survival. J Pediatr Surg. 2005 Aug;40(8):1275-8. doi: 10.1016/j.jpedsurg.2005.05.010.
Results Reference
result
PubMed Identifier
8641129
Citation
Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
Results Reference
result
PubMed Identifier
17660066
Citation
Kelly RE Jr, Shamberger RC, Mellins RB, Mitchell KK, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley TC, Moskowitz AB. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007 Aug;205(2):205-16. doi: 10.1016/j.jamcollsurg.2007.03.027. Epub 2007 Jun 21.
Results Reference
result
PubMed Identifier
23657247
Citation
Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.
Results Reference
result

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

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