Pectus Carinatum, Chondromanubrial Clinical Trial
Official title:
Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
| Verified date | October 2021 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 1, 2022 |
| Est. primary completion date | June 1, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Years to 16 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital de Clinicas da Faculdade de Botucatu | Botucatu | SP |
| Brazil | Hospital das Clinicas da Unicamp | Campinas | SP |
| Brazil | Hospital das Clinicas da USP Ribeirao | Ribeirão Preto | |
| Brazil | Instituto do Coracao (InCor) HCFMUSP | Sao Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088. Review. — View 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. — View 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 — View Citation
Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 16 months | |
| Primary | 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 | 16 months | |
| Secondary | 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 | 16 months | |
| Secondary | 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. | 16 months |