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

NCT ID: NCT04171063

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pectus Carinatum, Chondromanubrial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will be allocated to use the thoracic compressor for 16 months
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bracing arm

Patients that will be using the thoracic compressor

Group Type OTHER

Thoracic compressor

Intervention Type DEVICE

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

Interventions

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Thoracic compressor

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Miguel L. Tedde

Staff Physician, General Thoracic Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Tedde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coracao (InCor) HCFMUSP

Locations

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Hospital de Clinicas da Faculdade de Botucatu

Botucatu, São Paulo, Brazil

Site Status RECRUITING

Hospital das Clinicas da Unicamp

Campinas, São Paulo, Brazil

Site Status RECRUITING

Instituto do Coracao (InCor) HCFMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Hospital das Clinicas da USP Ribeirao

Ribeirão Preto, , Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Daniele Cataneo

Role: primary

+55(14) 3880-1529

Ricardo K Mussi

Role: primary

+55 (19) 3521-9450

Flavio Savazzi

Role: primary

+55(11) 2661-5708

Tales R Nadai

Role: primary

+55 (16) 3393-7865

References

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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.

Reference Type RESULT
PMID: 16080931 (View on PubMed)

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.

Reference Type RESULT
PMID: 8641129 (View on PubMed)

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.

Reference Type RESULT
PMID: 17660066 (View on PubMed)

Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.

Reference Type RESULT
PMID: 23657247 (View on PubMed)

Other Identifiers

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USaoPauloGH

Identifier Type: -

Identifier Source: org_study_id

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