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Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360502
First Posted: May 25, 2011
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Condition
Gastrointestinal Disease Anemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety of Capsule Endoscopy Using Human Body Communication in Patients With Cardiac Pacemakers and Implantable Cardiac Defibrillators

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 6
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: May 23, 2011
First Posted: May 25, 2011
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