跳至主要内容
临床试验/NCT01181362
NCT01181362已完成不适用

A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.

研究概览

简要总结

Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head & neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Between 18-70 years of age.
  • •Willing to give informed consent.

排除标准

  • •Allergy to topical anesthetic nasal spray (lidocaine).
  • •Patients who currently have or have had head and neck cancer.
  • •Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary).
  • •Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
  • •Concurrent illness, which prevents the subject from undergoing endoscopy.
  • •Disorders of the nasal cavity e.g deviated septum

研究组 & 干预措施

Endoscopy

Other

干预措施: Endoscopy (Procedure)

结局指标

主要结局

To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验