Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices
Condition: Cardiac Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The investigators hypothesise that ScopeGuide® does not create a magnetic field significant
      enough to interfere with the normal function of these devices. If true, patients with
      implanted cardiac devices can also be offered the benefit ScopeGuide® provides during
      colonoscopy.

      The justification for this research is that the ScopeGuide® is currently not used in patients
      with implantable electronic cardiac devices (pacemakers and implantable cardioverter
      defibrillators(ICDs)) due to the manufacturers advice. There are no case reports and no
      studies in the medical literature to confirm or refute the advice and the investigators have
      demonstrated no evidence of interference using a simulator.

      The number of patients with either a pacemaker or ICD is increasingly annually and with
      services such as the NHS bowel cancer screening programme in which colonoscopy is offered to
      patients with blood in their stool more of these patients are having this test.

      To deny these patients the use of the ScopeGuide®, which has been shown to reduce procedure
      duration, reduce patient discomfort and increase completion rate without evidence is
      unjustified.

      The investigators therefore believe that this project is justified to potentially allow
      patients with pacemakers or ICDs the benefit of ScopeGuide®. If the investigators demonstrate
      evidence of interference, it would demonstrate a lack of safety in this patient group.

      Due to the lack of data for the safety of ScopeGuide® for patients with implantable cardiac
      devices we seek to question the current absolute contraindication imposed by the
      manufacturer. The main question to be answered by this study is whether implantable cardiac
      devices exhibit interference when exposed to the ScopeGuide®.

      The population to be studied are individuals with implantable cardiac devices, attending
      their regular device check appointment at Addenbrooke's hospital. The age range will be 18 to
      80 years. Those being studied will be able to give informed consent.

      OBJECTIVES Primary Objective The primary objective of this study is to demonstrate in 100
      serial participants whether the ScopeGuide® causes interference with implantable cardiac
      devices.

      Secondary Objectives None STUDY DESIGN

      Summary of Study Design

      This study is an uncontrolled trial. The study method will be undertaken on 100 consecutive
      consenting participants.

      The participants will be required for one visit only. This will be during their routine
      implantable device check appointment. Participation will extend their routine check
      appointment time by around 30 minutes. Once they have completed the study procedure they will
      not be required for follow up visits.

      The duration of the study for an individual participant is as follows:

      Attend regular cardiac device check appointment (around 20 minutes) Exposure to ScopeGuide®
      device while being monitored (around 10 minutes) Repeat cardiac device check (around 20
      minutes)
    

Intervention name(s): Exposure to ScopeGuide
Intervention type(s): Device
Intervention description(s): The 2 minute protocol exposure to the electromagnetic field of the ScopeGuide device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic