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临床试验/NCT03468634
NCT03468634已完成不适用

Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy

University of Exeter2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)

研究概览

简要总结

To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

详细描述

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. The investigators intend to use this technique, known as "Raman Spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. It has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists.

A miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). This project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Barrett's oesophagus

排除标准

  • Unfit for endoscopic and biopsy assessment

结局指标

主要结局

Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)

时间窗: 6 months

Testing of the device for clinical application to demonstrate its use is safe and that is able to acquire diagnostic-quality (see outcome 2) spectra in less than 5 seconds from within the oesophagus. Samples illuminated will be biopsied and sent for routine histopathological analysis.

次要结局

  • Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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