Cardiac ArrhythmiaNCT01825525
Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices
A study testing Exposure to ScopeGuide in people with Cardiac Arrhythmia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Exposure to ScopeGuide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
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.
Read the 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)
- Conditions
- Cardiac Arrhythmia
- Being tested
- Exposure to ScopeGuide
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to ScopeGuideDevice
The 2 minute protocol exposure to the electromagnetic field of the ScopeGuide device.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac device patients. | Experimental | Exposure to ScopeGuide - patients with cardiac devices exposed to ScopeGuide as per study protocol Receives: Device: Exposure to ScopeGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment target met.
The study has a target recruitment of 100 patients. When this is met the study will stop.
Measured: 6 to 8 months
Secondary outcomes (1)
Interference seen with implanted cardiac device
If interference is seen in any of the recruited patients the study will be stopped.
Measured: 6 to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Gareth Corbett, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ewen AB Cameron, MD MB ChB, Study director, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825525
- Sponsor's protocol ID
- 12/EE0075
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Corbett GD, Lim YC, Lee JC, Chernolesskiy A, Pugh PJ, Cameron EA. Safety of the colonoscope magnetic imaging device (ScopeGuide) in patients with implantable cardiac devices. Endoscopy. 2014 Feb;46(2):135-8. doi: 10.1055/s-0033-1359044. Epub 2014 Jan 29.
PubMed 24477369
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices
- ClinicalTrials.gov ID
- NCT01825525
- Acronym / sponsor ID
- 12/EE0075
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac device patients. | Experimental | Device: Exposure to ScopeGuideExposure to ScopeGuide - patients with cardiac devices exposed to ScopeGuide as per study protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cardio-respiratory compromise on the day of the experiment (we propose NYHA Grade 3 or higher as criteria for this)
- Vulnerable adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to ScopeGuideThe 2 minute protocol exposure to the electromagnetic field of the ScopeGuide device. | Device | Cardiac device patients. |
Primary outcome
Recruitment target met.
Time frame: 6 to 8 months
The study has a target recruitment of 100 patients. When this is met the study will stop.
1 secondary outcome
Interference seen with implanted cardiac device
Time frame: 6 to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Derived from this study: PubMed 24477369Corbett GD, Lim YC, Lee JC, Chernolesskiy A, Pugh PJ, Cameron EA. Safety of the colonoscope magnetic imaging device (ScopeGuide) in patients with implantable cardiac devices. Endoscopy. 2014 Feb;46(2):135-8. doi: 10.1055/s-0033-1359044. Epub 2014 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewen AB Cameron, MD MB ChB study director
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to ScopeGuide in people with Cardiac Arrhythmia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment target met. (time frame: 6 to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.