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临床试验/NCT00523094
NCT00523094暂停不适用

Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

Deep Breeze1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
75
试验地点
1

研究概览

简要总结

The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who underwent surgical resection.

详细描述

Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able and willing to read, understand, and provide written informed consent;
  • Male or female in the age range of 18-80 years;
  • Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
  • Body mass index (BMI) > 21.

排除标准

  • Chest wall deformation;
  • Spine deformation (including scoliosis);
  • Potentially contagious skin lesion on the back;
  • Skin lesion that would interfere with sensor placement; (Keloids)
  • Cardiac pacemaker or implantable defibrillator;

研究者

发起方
Deep Breeze
申办方类型
Industry

研究点 (1)

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