Check-Cap Develops X-ray Pill for Imaging Colon

Capsule endoscopes with built-in cameras for imaging the GI tract are not new anymore, providing the ability to scan areas otherwise difficult to access and potentially replacing traditional upper and lower endoscopies with a less invasive, more dignified approach. Yet, they still require bowel prep cleansing and are limited to the visual spectrum. A new electronic pill from Check-Cap Ltd., however, features an X-ray source that can provide 3-D visualization of GI tract.

It’s currently an investigational device, but a study released this year showed safety and feasibility of colon imaging using the pill without bowel cleansing. The capsule is 30 mm in length and 11 mm in diameter and delivers a radiation dose similar to a dental X-ray. Moreover, unlike virtual CT colonoscopy, the radiation from the pill doesn’t have to penetrate the rest of the body to get to the colon, and maybe one day eclipsing that modality in GI imaging.

“Fewer than 20 percent of Europeans and 55 percent of Americans in the target population for colon screening actually undergo colonoscopies according to guidelines and one of the major hurdles is the burdensome preparation process required to thoroughly cleanse the bowel,” said lead investigator Nadir Arber, M.D., director of the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center in Israel, and president of the Israeli Society of Gastroenterology. “There is a critical need for increasing colon cancer screening compliance and a prep-free alternative could help overcome this significant hurdle.”

For this 10-case study (M=7, F=3) the Check-Cap high-resolution colon imaging capsule was ingested. The capsules were tracked during the passage using radio frequency telemetry and an electromagnetic localization system. The capsules also perform low-dose high resolution X-ray scans when movement in the colon is detected and transmit the imaging data to an external recorder unit worn by the patient.

The data obtained from the study demonstrated the safety and proof of concept of the Check-Cap Imaging System. All patients in the study ingested and naturally excreted the capsule without discomfort or side effects. In addition, using ultra-low dose equivalent to a dental X-ray or a flight from New York, N.Y., to London, United Kingdom, intra colonic 3-D circumferential imaging was achieved in the prep-less colon of human subjects with no prior cleansing.  A multi-center study is planned to further examine the clinical efficacy of the Check-Cap Imaging System for the detection of pre-cancerous polyps.

Based in Mount Carmel, Israel, Check-Cap develops gastrointestinal imaging devices. The company was founded in 2005.