a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint is reaching the cecum of the colon with PeerScope B S
研究概览
简要总结
The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.
The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.
The study population is comprised of patients indicated for colonoscopy.
The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:
- The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
- The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
- The third secondary endpoint is the procedure time.
- The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
- The fifth secondary endpoint is patient satisfactory.
详细描述
Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.
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
- 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 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 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
The primary endpoint is reaching the cecum of the colon with PeerScope B S
时间窗: 6 month
a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase
次要结局
未报告次要终点