Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers

Abstract

Objective: To assess the feasibility and safety of magnetic-controlled capsule endoscopy (MCE) system for examination of human stomach.

Methods: This pilot study enrolled 34 healthy volunteers. All subjects swallowed the MCE and gas-producing powder for gastric distention. An external robot was used to generate magnetic field to manipulate MCE inside the stomach. The primary measurements included safety, gastric preparation, maneuverability and visualization of gastric mucosa.

Results: Gastric preparation and examination was well accepted by subjects and there were no adverse events. The examination in the stomach takes 43.8±10.0min (27-60). The cleanliness was evaluated as good in the 30 (88.2%) subjects and as moderate in 4 (11.8%) subjects. The distention of gastric cavity was evaluated as good in the 29 (85.3%) subjects and moderate in 5 (14.7%) subjects. Maneuverability of the MCE to movements of the guidance magnet robot was graded as good in 29 (85.3%) subjects and moderate in 5 (14.7%) subjects. More than 75% gastric mucosa was visualized in 27 (79.4%) subjects and 50% to 75% in 7 (20.6%) subjects. Visualization of the gastric cardia, fundus, body, angulus, antrum and pylorus was subjectively assessed as complete in 82.4%, 85.3%, 100.0%, 100.0%, 100.0% and 100.0%, respectively. Polyp and erosive lesions were found in 7 subjects.

Conclusion: Magnetic-controlled capsule endoscopy used for examination of the human stomach is feasible and safe.

Keywords: capsule endoscopy; feasibility studies; magnetic-controlled; robot.

Figures

Figure 1

The AKE-1 magnetic-controlled capsule endoscopy. A. The prototype of AKE-1. B. The top view of AKE-1. C. The size of AKE-1 is 28×12mm. D. Data recorder and sensors placed on the patient's skin.

Figure 2

The front view of the magnetic-controlled capsule system.

Figure 3

The images of primary landmarks in stomach. A. cardia, B. fundus, C. body, D. angulus, E. antrum, F. pylorus.

Figure 4

A gastric polyp was found during magnetic-controlled capsule examination (A) and confirmed by the following gastroscopy (B).