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Third Eye Panoramic Device Feasibility Evaluation

2017年6月26日 更新者:Avantis Medical Systems

This study will evaluate the feasibility of using the Third Eye Panoramic device in conjunction with standard colonoscopes in a clinical setting.

Patients will undergo a colonoscopy procedure during which the study device will provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone.

The utility of the device will be assessed from the impressions of the investigators and from telephone follow-up with subjects to assess for post-procedural complications.

研究概览

地位

未知

详细说明

The purpose of this study is to evaluate the feasibility of using the Third Eye Panoramic device along with a standard colonoscope as a means of enhancing the ability of endoscopists to view areas that are hidden from the view of the colonoscope.

Colonoscopy is generally agreed to be the best method for detecting and removing cancers and pre-cancerous adenomas in the colon. However, numerous studies have demonstrated that from 22% to over 40% of adenomas are missed during standard colonoscopy. More importantly, 12% of large adenomas (at least 1 cm) are missed even by expert endoscopists using meticulous technique with the best available equipment, and these large adenomas are the ones that are most likely to transform into cancer.

Factors such as quality of bowel cleansing and time spent examining the colonic mucosa have been shown to affect miss rates. However, comparison with the results of CT colonography has shown that 2/3 of missed adenomas are located behind folds in the wall of the colon, in areas that are very difficult to see with a standard forward-viewing colonoscope.

When clipped onto the tip of a standard colonoscope, the Third Eye Panoramic device provides two additional miniature video cameras and light sources that offer views to the left side and right side of the colonoscope's tip. These lateral views complement the forward view of the colonoscope's camera to result in a "panoramic" view of over 300°. This extreme wide-angle view allows the endoscopist to examine the areas located behind folds.

In this study, each subject will undergo a colonoscopy procedure utilizing the Third Eye Panoramic device along with a standard colonoscope.

The investigators will evaluate issues related to usability and safety based on their experience and impressions, with telephone follow-up with subjects to assess for any post-procedural complications.

研究类型

介入性

注册 (预期的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Flushing、New York、美国、11355
        • New York Hospital Queens

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 75年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
  2. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

  1. Patients >75 years of age;
  2. Patients with a history of colonic resection;
  3. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
  4. Patients with diverticulitis or toxic megacolon;
  5. Patients with a history of radiation therapy to abdomen or pelvis;
  6. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:All subjects
All subjects will undergo examination with a Third Eye Panoramic device in conjunction with a standard colonoscope to evaluate the feasibility of using the study device to provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone.
A Third Eye Panoramic device will be attached to the tip of the colonoscope and will provide two additional views from laterally-oriented video cameras during the colonoscopy procedure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Device usability factors
大体时间:1 hour (average duration of procedure)
Device usability as measured by investigators' qualitative impressions regarding ease of use and any potential interference with function of colonoscope.
1 hour (average duration of procedure)

次要结果测量

结果测量
措施说明
大体时间
Device video factors
大体时间:1 hour (average duration of procedure)
Video image quality and ability to view areas behind folds as measured by investigators' qualitative impressions
1 hour (average duration of procedure)
Patient safety assessed by number of subjects with adverse events as a measure of safety and tolerability
大体时间:At time of procedure and up to 48 hours after completion of procedure
Number of subjects with adverse events
At time of procedure and up to 48 hours after completion of procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Moshe Rubin, MD、New York Hospital Queens - Weill Cornell Medical College

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年11月12日

初级完成 (预期的)

2017年10月11日

研究完成 (预期的)

2017年10月11日

研究注册日期

首次提交

2015年2月11日

首先提交符合 QC 标准的

2015年2月20日

首次发布 (估计)

2015年2月23日

研究记录更新

最后更新发布 (实际的)

2017年6月27日

上次提交的符合 QC 标准的更新

2017年6月26日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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