Usefulness of a real-time capsule endoscopy for improvement of the image quality

UMIN ID: UMIN000002003

Registered date:29/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: small intestinal disorders
• Date of first enrollment: 2009/05/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A real-time viewer was attached to the patient. At the 60 min after swallowing the capsule, if the capsule was still located in the stomach, 10mg of metoclopramide was given intramuscularly, and then 500ml of polyethylene glycol solution was given to the patient. At the 60 min after swallowing the capsule, if the capsule reached the small bowel, 500ml of polyethylene glycol solution was given to the patient without administration of metoclopramide.
The capsule endoscopy was done without using a real-time viewer, and no preparation was done.

Outcome(s)

• Primary Outcome: image quality of capsule endoscopy
• Secondary Outcome: completion rate to the cecum

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: a. The patients with dysphagia. b. Pregnant or lactating women. c. The patients who have history of the ileus or stricture or fistula of the intestine. d. The patient with pacemaker or other medical electronic equipment. e. A history of abdominal surgery. f. The subject of any other clinical test/trial which will affect the results this study. g. Can not comply with the study requirements or cannot follow instructions for the device.

Related Information

• Primary Sponsor: Yokohama City University Graduate School of Medicine
• Source(s) of Monetary Support: Yokohama City University Graduate School of Medicine