A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 7
- 主要终点
- Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
研究概览
简要总结
The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system.
The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps.
Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.
详细描述
THE STUDY DEVICE:
The Third Eye Retroscope is a thin, flexible probe that can be inserted in a standard colonoscope in order to display very detailed images of the colon tissue. It contains a miniature video camera that allows the doctor to see an additional point of view that looks backward while the regular colonoscope and study device are moved together through the length of the colon.
For you to be eligible to take part in this study, your doctor will check to be sure you have no medical conditions that would increase your risk of having any complications as a result of having the study device used during your colonoscopy.
STUDY PROCEDURES:
If you are found to be eligible to take part in this study, your doctor will perform your colonoscopy exam in the usual manner except that the Third Eye Retroscope device will be used during the exam as well. Your doctor will insert the colonoscope into your rectum in the usual manner and will then insert the study device down a channel inside the colonoscope. You will sign a separate consent form for the colonoscopy, which will describe the procedure and its risks in more detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy.
- •The patient is at satisfactory risk for abdominal surgery.
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Patients who are <50 years or >80 years of age
- •Patients who are pregnant.
- •Patients with history of colonic resection.
- •Patients requiring ongoing anticoagulation therapy.
- •Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
- •Patients with hypersensitivity to opioid analgesics.
- •Patients with an active systemic infection.
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy.
- •Patients with major psychiatric disease (dementia, schizophrenia or depression).
- •Patients with diverticulitis or toxic megacolon.
- •Patients with history of radiation therapy to abdomen or pelvis.
- •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.
研究组 & 干预措施
Third Eye Retroscope
Colonoscopy exam using the Third Eye Retroscope device
干预措施: Third Eye Retroscope Auxiliary Imaging System (Device)
结局指标
主要结局
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
时间窗: Total 30 minutes procedure time with TER use.
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)
时间窗: Total 30 minutes procedure time with TER use.
After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
次要结局
- Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.(2 year study period to collect colonoscopy exam results)