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临床试验/NCT01618721
NCT01618721终止不适用

Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

Echosense Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
1
主要终点
Characterization of Lung Doppler signals obtained from different lung diseases.

研究概览

简要总结

The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able and willing to provide informed consent
  • Age 18 years or older
  • Clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible.
  • Evaluation by a physician who determines that a High Resolution Computed Tomography (HRCT) of the Thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care.
  • If full lung function tests are normal imaging with a regular chest x-ray is sufficient.
  • Study Population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and HRCT of the thorax -
  • COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC < 0.70).
  • Interstitial lung disease (ILD) diagnosed by HRCT.
  • Control subjects presenting with pulmonary complaints evaluated by full PFTs (spirometry, lung volume and DLCO) and a chest x-ray and/or HRCT , all found to be within normal limits, .

排除标准

  • Primary or metastatic lung cancer.
  • Acute pneumonia.
  • Concomitant or previous diagnosis of Bronchial Asthma.
  • Patients with severe chest wall deformity
  • Decompensated heart failure or volume overload.
  • Significant right-sided pleural effusion.

结局指标

主要结局

Characterization of Lung Doppler signals obtained from different lung diseases.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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