SMART Medical Systems has announced that its G-Eye balloon technology showed an increase in the detection rate of colon adenomas in a clinical trial compared to Endocuff Vision (ECV) technology.
The randomised, multicentre clinical study (NCT 04708951) compared the adenoma detection rate (ADR) of its technology, which is cleared by the US Food and Drug Administration (FDA) in patients undergoing colonoscopy screening.
The company stated that the ADR, especially for advanced and large adenomas, was higher for the G-EYE balloon compared to ECV attachment in the trial.
Colonoscopy is colorectal cancer (CRC) prevention’s gold standard, but folds within the colon may harbour adenomas (pre-cancerous polyps) that cannot be seen during the exam.
It is noted that both the technologies are designed to assist colonoscopy by mechanical manipulation increasing colon surface area exposure.
In the trial, 935 patients with similar characteristics were randomised for G-Eye or ECV-assisted colonoscopy.
It was found that the ADR of patients using G-EYE technology increased by 18% overall and a 69% increase was observed in advanced adenomas ADR.
Furthermore, the detection of an additional 83% large adenomas and 87% advanced adenomas was supported by G-EYE compared to ECV.
SMART Medical CEO Gadi Terliuc said: “The effect of the G-EYE balloon is notable, and I expect it to become a standard tool, over time, for every colonoscopy.
“These new data add to the growing body of clinical evidence demonstrating that G-EYE provides endoscopists with increased diagnostic yield, and we are gratified that the American College of Gastroenterology (ACG) has recognised the importance of these findings by selecting this abstract for the Outstanding Research Award in the colon cancer prevention category.”