Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

NCT ID: NCT01360502

Last Updated: 2011-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Disease Anemia

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University College of Medicine

Principal Investigators

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

Role: STUDY_CHAIR

Yonsei University

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2009-0021

Identifier Type: -

Identifier Source: org_study_id

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