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Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

2018年8月17日 更新者：Sergey Kantsevoy、Mercy Medical Center

A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon

Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum.

Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon for performance of colonoscopy.

Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention, patient's discomfort, use of sedatives and analgetics during procedure and will simplify the performance of colonoscopy resulting in shortening of procedure time and increasing the rate of cecal intubation.

Specific aims of the study:

  1. To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy with traditional CO2-insufflation colonoscopy.
  2. To compare safety profiles between traditional CO2-insufflation colonoscopy and colonoscopy using the "Visualization" Balloon.

4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with "Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with standard colonoscopy using CO2 insufflation.

4.2 Secondary Outcomes

To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in regards of:

  1. Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the procedure.
  2. Ease of colonoscope insertion.
  3. The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time and total procedure time.

5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7. Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.

8. Complications during and after colonoscopy. 9. Polyp detection rate.

研究类型

介入性

注册 (实际的)

216

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

  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21202
        • Mercy Medical Center

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

17年 至 90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 colo-rectal cancer screening, polypectomy or for diagnostic workup.
  2. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
  3. Age from 17 to 90 years.
  4. Be willing and able to comply with the requirements of the protocol.
  5. Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
  6. Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria:

  1. Subjects with a history of previous colonic resection.
  2. Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
  3. Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
  4. Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
  5. Subjects who received any experimental drug or device within the previous three months.
  6. Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
  7. Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Visualization balloon
Colonoscopy performed with the use of "Visualization" balloon
设备：Visualization balloon
The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.
有源比较器：Traditional CO2-insufflation colonoscopy
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
设备：Traditional CO2 insufflation colonoscopy
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

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
Cecal intubation time
大体时间：Immediately
Time required to reach cecum
Immediately

次要结果测量

结果测量
措施说明
大体时间
Length of colonoscope when it reaches cecum
大体时间：Immediately
Total length of colonoscope when it reaches cecum
Immediately
Ease of colonoscope insertion
大体时间：Immediate
Easy of colonoscope insertion to cecum
Immediate
Dose of analgesics and sedatives used
大体时间：Immediately
Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
Immediately
Patient satisfaction
大体时间：Immediately and in 24 hours
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
Immediately and in 24 hours
Total procedure time
大体时间：Immediately
Total time required to complete colonoscopy
Immediately

其他结果措施

结果测量
措施说明
大体时间
Amount of carbon dioxide used
大体时间：Immediately
Total amount of carbon dioxide used during colonoscopy
Immediately

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。

赞助

Mercy Medical Center

调查人员

  • 首席研究员：Sergey V Kantsevoy, MD, PhD、Mercy Medical Center

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

2014年3月1日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2014年4月11日

首先提交符合 QC 标准的

2014年4月15日

首次发布 (估计)

2014年4月17日

研究记录更新

最后更新发布 (实际的)

2018年8月21日

上次提交的符合 QC 标准的更新

2018年8月17日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • VB-001

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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