NCT04171063

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

Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Thoracic compressor	The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2019-11-20
• Last updated: 2021-10-12

Locations

4 sites across 1 country: Brazil