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Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

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ClinicalTrials.gov Identifier: NCT01360502
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
Yonsei University

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

Condition or disease
Gastrointestinal Disease Anemia

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.

Study Type : Observational
Actual Enrollment : 6 participants
Time Perspective: Prospective
Official Title: Safety of Capsule Endoscopy Using Human Body Communication in Patients With Cardiac Pacemakers and Implantable Cardiac Defibrillators
Study Start Date : December 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources





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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with implantable cardiac devices
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360502


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Si Young Song, M.D., Ph.D. Yonsei University

Responsible Party: Si Young Song, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT01360502     History of Changes
Other Study ID Numbers: 1-2009-0021
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: September 2009

Keywords provided by Yonsei University:
capsule endoscopy
cardiac pacemaker
implantable cardiac defibrillator

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases