Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study
NCT ID: NCT04171063
Last Updated: 2021-10-12
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-11-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bracing arm
Patients that will be using the thoracic compressor
Thoracic compressor
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
Eligibility Criteria
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Inclusion Criteria
* No other comorbidities that could interfere with the use of compressor
Exclusion Criteria
* Active cardiovascular disease
* Significant scoliosis or thoracic deformity
* Important obesity
* Pectus carinatum chondromanubrial variant
* Poor commitment to protocol by both research participant and parents
6 Years
16 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Miguel L. Tedde
Staff Physician, General Thoracic Surgery Department
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
Hospital das Clinicas da Unicamp
Campinas, São Paulo, Brazil
Instituto do Coracao (InCor) HCFMUSP
São Paulo, São Paulo, Brazil
Hospital das Clinicas da USP Ribeirao
Ribeirão Preto, , Brazil
Countries
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Facility Contacts
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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.
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.
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.
Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.
Other Identifiers
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USaoPauloGH
Identifier Type: -
Identifier Source: org_study_id
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