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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 23, 2011

Last Updated Date

May 24, 2011

Start Date ^ICMJE

December 2009

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01360502 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients with implantable cardiac devices

Condition ^ICMJE

Gastrointestinal Disease
Anemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01360502

Other Study ID Numbers ^ICMJE

1-2009-0021

Has Data Monitoring Committee

Yes

Responsible Party

Si Young Song, Yonsei University College of Medicine

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Si Young Song, M.D., Ph.D.

Yonsei University College of Medicine

Information Provided By

Yonsei University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top