Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recruitment target met.
研究概览
简要总结
The Olympus ScopeGuide® is a useful tool in speeding up colonoscopy and making it less painful for patients. It is currently contraindicated by the manufacturer for use with patients with implantable electronic devices (such as cardiac pacemakers). There is no evidence to back up this contraindication and with the number of pacemakers being inserted increasing by around 30 000 annually in the UK, more patients will be denied the use of this device should they require a colonoscopy.
Participants with Pacemakers or Implantable Cardioverter Defibrillators will attend their check appointment. Following this they will be asked to lie with a colonoscope connected to the ScopeGuide® placed onto their abdomen (with clothes on) for 2 minutes. During this time they will be monitored for any irregular cardiac activity which may indicate electromagnetic interference. After this a second device check will occur and the participant will be sent home.
The hypothesis is that the ScopeGuide will not interfere with the cardiac devices.
详细描述
BACKGROUND AND RATIONALE
Colonoscopy is the 'gold-standard' diagnostic procedure for visualising the inside of the large bowel. It involves the insertion of a flexible instrument called a "colonoscope" around the large bowel. During insertion, looping of the instrument inside the colon can lead to incomplete procedures and significant patient discomfort.
The development of the colonoscope magnetic imaging device (Olympus ScopeGuide®) has allowed the doctor performing the examination to detect looping of the instrument more easily. It has been shown in several studies that the duration, patient experience and completion rate of colonoscopy can be significantly improved by the use of ScopeGuide®.
The manufacturer advises against the use of ScopeGuide® for patients with implantable devices due to the theoretical hazard of electromagnetic interference leading to device malfunction. Therefore, patients with permanent pacemakers and implantable cardioverter-defibrillators (ICDs) who require colonoscopy are denied the potential benefits offered by ScopeGuide®. There is no documented evidence for this risk from case reports or studies and the investigators have used a simulator to demonstrate that ScopeGuide® caused no interference or malfunction.
The investigators propose an experimental study to evaluate the impact of the electromagnetic field created by ScopeGuide® on the implanted cardiac devices in patients. The study will be conducted in the Pacemaker Outpatient Clinic at Addenbrooke's hospital by a team of investigators including gastroenterologists and cardiologists. After giving their consent to participate, enrolled patients will have the activity of their cardiac device closely monitored while in close proximity to ScopeGuide® and any effect of this on the cardiac devices will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Must have a permanent pacemaker or implantable cardioverter defibrillator
- •Is attending for a routine pacemaker check during the study period
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Cardio-respiratory compromise on the day of the experiment (we propose NYHA Grade 3 or higher as criteria for this)
- •Vulnerable adults
结局指标
主要结局
Recruitment target met.
时间窗: 6 to 8 months
The study has a target recruitment of 100 patients. When this is met the study will stop.
次要结局
- Interference seen with implanted cardiac device(6 to 8 months)
研究者
Dr Gareth Corbett
Specialist Registrar, Gastroenterology
Cambridge University Hospitals NHS Foundation Trust