Original articleClinical endoscopyFirst clinical trial of the “MiRo” capsule endoscope by using a novel transmission technology: electric-field propagation
Section snippets
Study design
Healthy volunteers (26 men, 23 women; aged 23–57 years; mean age 38.9 years) were enrolled at 2 hospitals in Korea. All volunteers gave informed consent according to the requirements of the local and government ethics committees. This clinical trial was approved by the Korean Food and Drug Administration and by the institutional review boards at the participating hospitals.
Before enrollment, we performed screening tests for health problems, including routine electrocardiography (ECG), chest and
Results
After screening the subjects, 4 subjects were dropped from the trial. One was diagnosed as having liver cirrhosis with esophageal varices, two showed ECG abnormalities, and one withdrew consent before swallowing the capsule. Thus, a total of 45 volunteers participated. The mean age was 38.9 years (23–57 years), and 26 were men.
Discussion
Since the introduction of capsule endoscopy in GI-tract diagnostics, the paradigm for choosing diagnostic tools in GI disorders has changed.1, 2, 3 Exploration of the small bowel is now possible without discomfort to patients or without the need for a well-trained endoscopist. However, conventional CE has had important limitations, such as the duration of image capture in the human body.8 Furthermore, images captured in the GI tract have not shown sufficiently fine resolution compared with
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DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. This multicenter trial was supported by the 21st Century Frontier R&D Project (F0001004-2006-31), sponsored by the Korean Ministry of Commerce, Industry, and Energy, and by Intromedic.
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See CME section; p. 303.