Wireless Capsule Endoscopy as a Diagnostic Technique

BCBS - Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus and Colon

DESCRIPTION

Wireless capsule endoscopy is performed using the PillCamTM Given® Diagnostic Imaging System, (previously called M2A® ), which is a disposable imaging capsule manufactured by Given Imaging, Ltd (Norcross, GA). The capsule measures 11 by 30 mm and contains video imaging, self-illumination, and image transmission modules as well as a battery supply that lasts for up to 8 hours. The indwelling camera takes images at a rate of 2 frames per second as peristalsis carries the capsule through the gastrointestinal tract. The average transit time from ingestion to evacuation is 24 hours. The device uses wireless radio transmission to send the images to a receiving recorder device that the patient wears around the waist. This receiving device also contains some localizing antennae sensors that can roughly gauge where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.

The device received marketing clearance from the U.S. Food and Drug Administration (FDA) on August 1, 2001, through a 510(k) approval process. The FDA clearance provides for the capsule's use "along with – not as a replacement for – other endoscopic and radiologic evaluations of the small bowel." The FDA clarified that the "capsule was not studied in the large intestine." On July 1, 2003, a supplemental 510(k) pre-market notification was cleared and the labeled indications were modified by removing the “adjunctive” use qualification:
"The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel."

Finally, in November 2004, the device received FDA clearance for the following labeled indication: "the Given®  Diagnostic System with the PillCamTM ESO Capsule is intended for the visualization of esophageal mucosa." A new model was cleared by the FDA in June 2007, the PillCam ES02 Capsule.
In September 2007, the FDA cleared the Olympus Capsule Endoscope System through the 510(k) process for “visualization of the small intestine mucosa.” More recent versions of both of these systems also incorporate a blood indicator feature to assist with rapid screening of intestinal lesions with bleeding potential.

In the small bowel, the capsule camera has been most frequently proposed as a technique to identify the source of obscure intestinal bleeding, although recently there has been interest in exploring its use in patients with inflammatory bowel disease. Alternative diagnostic techniques include barium studies or small intestinal endoscopy. In the esophagus, the capsule camera has been proposed as a screening technique for Barrett's esophagus associated with gastroesophageal reflux disease (GERD). Evaluation of the esophagus requires limited transit time, and it is estimated that the test takes 20 minutes to perform. Alternative techniques include upper endoscopy.

In 2006, the FDA also provided clearance for the Given AGILE patency system. This system is an accessory to the PillCam video capsule and according to FDA material is intended to verify adequate patency of the GI tract prior to administration of the PillCam in patients with known or suspected strictures. This capsule is of similar size to the endoscopy capsule, but is made of lactose and barium and dissolves within 30-100 hours of entering the GI tract. It carries a tracer material that can be detected by a scanning device. Excretion of the intact capsule without symptoms (abdominal pain or obstruction) is reported to predict the uncomplicated passage of the wireless capsule.