Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 6
- 主要终点
- polyp detection rate
研究概览
简要总结
The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.
Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.
In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
详细描述
Design:
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.
Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy. Subjects in Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.
Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for total polyps and detection rates for adenomas. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24 hour and a 7 days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject between the ages of 18 and 70
- •The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- •Written informed consent must be available before enrollment in the trial
- •For women with childbearing potential, adequate contraception
排除标准
- •Patients with a history of colonic resection;
- •Patients with known (or newly diagnosed) inflammatory bowel disease;
- •Patients with a personal history of polyposis syndrome;
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- •Patients with diverticulitis or toxic megacolon;
- •Patients with a history of radiation therapy to abdomen or pelvis;
- •Patients with acute lower GI bleeding
- •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.
结局指标
主要结局
polyp detection rate
时间窗: 1 year
Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope System™ extended view as compared to Standard view colonoscopy. Total sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope System™ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices.
次要结局
未报告次要终点