Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

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

Completed

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Key information

Conditions

Gastrointestinal Disease Anemia Digestive System Diseases Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 20 years or older
cardiac pacemaker or implantable cardiac defibrillator
gastrointestinal disease

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: May 25, 2011
Registry last updated: May 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed