Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01360502
First received: May 23, 2011
Last updated: May 24, 2011
Last verified: September 2009
  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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Si Young Song, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT01360502     History of Changes
Other Study ID Numbers: 1-2009-0021
Study First Received: May 23, 2011
Last Updated: May 24, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014