Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360502
• Other study ID #: 1-2009-0021
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: May 24, 2011
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of,