8 Devices & Tests Designed to Improve Colorectal Cancer Screening
Polyp and adenoma detection
Polyp and adenoma detection rates are two key colonoscopy quality metrics, which are increasingly becoming requisites in the GI field. The device industry has responded with efforts to improve visualization.
• EndoCuff. A recent study compared EndoCuff-assisted colonoscopy and traditional colonoscopy. The study found the number of polyps detected in the EndoCuff group was 63 percent higher and adenoma detection rate increased 86 percent with EndoCuff use. The researchers concluded that the device boosted polyp detection and ADR, particularly in the cecum and sigmoid colon.
• Fuse Endoscopy System. The Full Spectrum Endoscopy System from EndoChoice provides physicians with an expanded field of view, 330 degrees for a colonoscope compared to the 170 degree field of view in a traditional scope. In a multicenter international study, researchers found that standard colonoscopes missed 41 percent of adenomas, while the Fuse Endoscopy System detected 69 percent more adenomas than the traditional scopes.
• JET PREP Endoscopic Flushing Device. Medivators launched the JET PREP device this month. The novel irrigation and suction device is designed to clear and remove debris during a colonoscopy, thus improving visualization and polyp detection. Additionally, the device is geared towards reducing the cost of colonoscopy caused by repeat procedures due to poor bowel preparation.
Patients may be reluctant to undergo colonoscopy, despite the wealth of information touting its benefits, or may not be good candidates for the procedure. The industry has offered alternatives, including home-based tests which are continually honed for accuracy.
• Fecal immunochemical test. In an Annals of Internal Medicine study published in February, researchers compared FIT to the fecal occult blood test, both at-home colorectal cancer tests. The researchers found that FIT was able to accurately detect 79 percent of colorectal cancers, while FOBT detected 50 percent or lower.
• Cologuard. FIT is not the only stool-based colorectal cancer test to contend with. In March, Exact Sciences published the results of its DeeP-C clinical study comparing the efficacy of Cologuard, a multi-target stool DNA-based screening test, to FIT. In this study, researchers found Cologuard detected 92 percent of colorectal cancers, compared to 74 percent in FIT. The researchers also found:
• Cologuard detected 93 percent of colorectal cancers in Stages I-III, while FIT detected 73 percent
• Cologuard demonstrated a 42 percent sensitivity level in patients with advanced precancerous lesions, while FIT demonstrated 24 percent sensitivity
• Cologuard detected 69 percent of patients with high-grade dysplasia polyps, while FIT detected 46 percent
• Cologuard had a specificity of 87 percent, while FIT had specificity of 95 percent
The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has recommended approval of the test. The FDA is not obligated to follow the advisory committee's recommendation, but will consider its guidance as Cologuard is evaluated.
Patient discomfort can affect procedure outcome and even stop patients from getting screened. Capsule endoscopy offers patients an alternative to colonoscopy. On the other hand, advances in bowel preparation have made headway in alleviating some of the apprehension surrounding the day before a colonoscopy.
• ENDOCAPSULE 10 System. Olympus commercially launched its ENDOCAPSULE 10 System in May. Olympus's 510(k) cleared, minimally invasive system aims to improve diagnostic capability, efficiency and patient comfort. The system has a 160 degree field of view, 12-hour battery life, 3D tracking function and a recording unit that be worn over clothing.
• PillCam COLON. Given Imaging received FDA clearance for its PillCam COLON in February. The device is considered an option for patients after an incomplete optical colonoscopy. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.
• Prepopik. Prepopik has been FDA-approved since 2012. A study found that 58.4 percent of patients reported the low-volume solution "very easy" to take, while an additional 29 percent found it "easy." The Ferring Pharmaceuticals preparation, made of 10 grams of sodium picosulfate, 3.5 grams of magnesium oxide and 12 grams of citric acid, is to be administered in two five-ounce glasses and followed with clear liquids. Patients consume a total of two liters.
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