Post Market Evaluation of Aer-O-Scope Visualization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Adenoma Miss Rates
研究概览
简要总结
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.
详细描述
Subjects will be randomized in blocks of twenty (20) for either Aer-O-Scope or conventional colonoscopy as the first procedure. Physicians will be notified of the procedural order immediately prior to first colonoscopy. Up to the first ten (10) cases for each physician (system operation training cases) will all begin with the Aer-O-Scope colonoscopy as the first procedure.
The primary endpoint of AMR was chosen as this measure appears to be related to the performance of colonoscopy and reduction in colorectal cancer incidence. During the course of the last decade, several major visualizations studies have been performed and it has become common practice to use the "second-pass" method for measuring colonoscopy visualization methods, iii, iv. In the "second-pass" method, during the course of the first colonoscopy, all visualized lesions are removed (or tattooed in the event that they cannot be removed for any reason.). Any unmarked abnormalities discovered during the second pass colonoscopy are considered to be missed pathologies for the first pass colonoscopy.
All endpoints related to timing will be measured using a stopwatch and overall time stamp from the Aer-O-Scope or conventional colonoscope. Time to perform therapeutic interventions with Aer-O-Scope as well as a description of said interventions will also be recorded. The same instruments will be used to measure all procedures and will be calibrated as dictated by the manufacturer.
All equipment used during the course of this clinical investigation will undergo calibration and testing as per the manufacturing instructions. The Aer-O-Scope Colonoscope System has an automated calibration system and diagnostic test that run daily. Conventional colonoscopes will be maintained as per hospital/manufacturer protocol.
Recruited subjects who are withdrawn as a result of poor bowel prep or any other medical determination leading to the inability to undergo colonoscopy and/or tandem colonoscopy will be replaced. A poor prep is defined as having a score of score of 0 or 1 in the Boston Bowel Preparation Scale (BBPS). The BBPS scores are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
- •Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a conventional colonoscope (including a single colon preparation bowel cleansing)
- •Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
- •Subject is able to understand and willing to sign informed consent form
排除标准
- •Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
- •Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- •Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
- •History of colonic resection
- •Clinically significant cardiovascular or pulmonary disease.
- •Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
- •Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
- •Previous radiation therapy to the abdomen
- •Morbid Obesity (BMI > 40 kg/m2)
- •Drug abuse or alcoholism
- •Subject is bed-ridden and/or unable to adequately communicate
- •Subject is under custodial care
- •Subject has a history of psychiatric disorders which would prevent compliance with study instructions
- •Participation in a clinical study within the previous 30 days
研究组 & 干预措施
Aer-O-Scope First
Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope
干预措施: Aer-O-Scope (Colonoscopy) (Device)
Aer-O-Scope First
Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope
干预措施: Colonoscopy (Conventional Colonoscope) (Procedure)
Conventional Colonoscope First
Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope
干预措施: Aer-O-Scope (Colonoscopy) (Device)
Conventional Colonoscope First
Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope
干预措施: Colonoscopy (Conventional Colonoscope) (Procedure)
结局指标
主要结局
Adenoma Miss Rates
时间窗: Through study completion, an average of one year
Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology. Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved. Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)
次要结局
- Polyp Miss Rates (PMR) for Each Study Arm(Through study completion, an average of one year)
- Advanced Adenoma Miss Rates (AAMR) for Each Study Arm(Through study completion, an average of one year)