Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices

NCT01825525 | Completed DMC

• 1 other identifier: 12/EE0075
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Recruitment target met.

  The study has a target recruitment of 100 patients. When this is met the study will stop.

  6 to 8 months

Secondary Outcomes (1)

• Interference seen with implanted cardiac device

  6 to 8 months

Study Arms (1)

Cardiac device patients.

EXPERIMENTAL

Exposure to ScopeGuide - patients with cardiac devices exposed to ScopeGuide as per study protocol

Device: Exposure to ScopeGuide

Interventions

Exposure to ScopeGuide DEVICE

The 2 minute protocol exposure to the electromagnetic field of the ScopeGuide device.

Cardiac device patients.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24477369 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ewen AB Cameron, MD MB ChB

  Cambridge University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar, Gastroenterology

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 5, 2013
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

GB (1)