跳至主要内容
临床试验/NCT02359409
NCT02359409撤回不适用

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Indiana University1 个研究点 分布在 1 个国家开始时间: 2014年7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
撤回
试验地点
1
主要终点
number of subjects with complete colonoscopy in each arm

研究概览

简要总结

This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.

详细描述

About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Referral for incomplete colonoscopy

排除标准

  • •Known stricture or narrowing of the colon, prior colon resection

研究组 & 干预措施

water immersion only

Active Comparator

Colonoscopy will be performed using the water immersion technique.

干预措施: water immersion only (Other)

water immersion with goggle balloon

Experimental

Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique

干预措施: goggle balloon (Device)

结局指标

主要结局

number of subjects with complete colonoscopy in each arm

时间窗: 2 years

次要结局

  • Time to cecal intubation in each arm(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas K. Rex

Director of Endoscopy

Indiana University

研究点 (1)

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