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临床试验/NCT04171063
NCT04171063Unknown不适用

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

University of Sao Paulo4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
4
主要终点
Treatment safety

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pectus carinatum condrogladiolar Variant
  • No other comorbidities that could interfere with the use of compressor

排除标准

  • 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

结局指标

主要结局

Treatment safety

时间窗: 16 months

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

Treatment efficiency in repairing the pectus carinatum

时间窗: 16 months

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

次要结局

  • Device durability(16 months)
  • Treatment adherence(16 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel L. Tedde

Staff Physician, General Thoracic Surgery Department

University of Sao Paulo

研究点 (4)

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