Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

Completed

• Conditions: Gastrointestinal Disease; Anemia

• Registration Number: NCT01360502
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-09
• Study Start: 2009-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-24
• Last Update Submitted: 2011-05-24
• Study First Posted: 2011-05-25
• Last Update Posted: 2011-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of