Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

Safety of Capsule Endoscopy Using Human Body Communication in Patients With Cardiac Pacemakers and Implantable Cardiac Defibrillators

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360502

Enrollment

Registered

2011-05-25

Start date

2009-12-31

Completion date

2011-02-28

Last updated

2011-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Gastrointestinal Disease

Keywords

capsule endoscopy, cardiac pacemaker, implantable cardiac defibrillator

Brief summary

This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Detailed description

MiroCam (IntroMedic, Ltd, Seoul, Korea) is a small bowel capsule endoscope using human body communication for data transmission. There is a concern of potential interactions between cardiac devices and capsule endoscope. This clinical study was designed to evaluate the potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. age 20 years or older 2. cardiac pacemaker or implantable cardiac defibrillator 3. gastrointestinal disease

Exclusion criteria

1. previous GI perforation or obstruction history 2. known or suspected GI stricture 3. marked GI dysmotility 4. uncompensated heart failure (EF ≤30% or Killip's classification class ≥ III) 5. pregnancy

Countries

South Korea

Outcome results