Elsevier

Gastrointestinal Endoscopy

Volume 69, Issue 2, February 2009, Pages 253-259
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
First clinical trial of the “MiRo” capsule endoscope by using a novel transmission technology: electric-field propagation

https://doi.org/10.1016/j.gie.2008.04.033Get rights and content

Background

We developed a capsule endoscope (CE), “MiRo,” with the novel transmission technology of electric-field propagation. The technology uses the human body as a conductive medium for data transmission. Specifications of the prototype include the ability to receive real-time images; size, 10.8 × 24 mm; weight, 3.3 g; field of view, 150°; resolution of power, 320 × 320 pixels; and transmittal speed, 2 frames per second.

Objective

To evaluate the clinical safety and diagnostic feasibility of the prototype MiRo, we conducted a multicenter clinical trial.

Design and Patients

All volunteers underwent baseline examinations, including EGD and electrocardiography for the screening of GI obstructive and cardiovascular diseases, before the trial. In the first 10 cases, 24-hour Holter monitoring was also performed. To evaluate the diagnostic feasibility, transmission rate of the captured images, inspection rate of the entire small bowel, and quality of transmitted images (graded as outstanding, excellent, good/average, below average, and poor) were analyzed.

Results

Of the 49 healthy volunteers, 45 were included in the trial, and 4 were excluded because of baseline abnormalities. No adverse effects were noted. All CEs were expelled within 2 days, and the entire small bowel could be explored in all cases. The transmission rates of the captured image in the stomach, small bowel, and colon were 99.5%, 99.6%, and 97.2%, respectively. The mean total duration of image transmission was 9 hours, 51 minutes, and the mean transit time of the entire small bowel was 4 hours, 33 minutes. Image quality was graded as good or better in 41 cases (91.1%). Details of the villi and vascular structures of the entire small bowel were clearly visualized in 31 cases (68.9%).

Conclusions

MiRo is safe and effective for exploring the entire small bowel, with good image quality and real-time feasibility. This novel transmission technology may have applications beyond the field of capsule endoscopy.

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

References (12)

There are more references available in the full text version of this article.

Cited by (114)

View all citing articles on Scopus

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.

If you want to chat with an author of this article, you may contact him at [email protected].

See CME section; p. 303.

View full text