First clinical trial of the "MiRo" capsule endoscope by using a novel transmission technology: electric-field propagation.

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 x 24 mm; weight, 3.3 g; field of view, 150 degrees; resolution of power, 320 x 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.