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临床试验/NCT00672893
NCT00672893已完成不适用

Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

Deep Breeze5 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
5
主要终点
The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.

研究概览

简要总结

Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
  • Male or female in the age range of 18-85 years.
  • Body Mass Index >
  • Patient presented with airway obstruction and who are designated to undergo intervention

排除标准

  • Chest wall deformity;
  • Spine deformity (including severe scoliosis or kyphosis);
  • Hirsutism;
  • Potentially contagious skin lesion on the back;
  • Skin lesion that would interfere with sensor placement;
  • Patient is pregnant;
  • Cardiac pacemaker or implantable defibrillator;

结局指标

主要结局

The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.

时间窗: Baseline and follow-up up to 3 months

次要结局

  • The secondary objective is to assess the contribution of the VRI in aiding in identification of the pulmonary obstruction as compared to the standard methods prior the intervention procedure.(Baseline)

研究者

发起方
Deep Breeze
申办方类型
Industry

研究点 (5)

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