SMART Medical’s G-EYE® Balloon Beats ENDOCUFF VISION® in Colon Adenoma Detection Study

The Adenoma Detection Rate (ADR) was higher for the G-EYE® balloon than for the EndoCuff Vision (ECV) attachment, says a new randomized study.

Background

SMART Medical Systems Ltd., develops and manufactures innovative endoscopy products including its FDA-cleared G-EYE® balloon. The G-EYE® balloon, which is inflated to sub-anchoring pressure during endoscope withdrawal, unfolds the colonic topography, stabilizes the colonoscope in the center of the colon lumen to help maintain the field of view during the examination and allows for a more controlled withdrawal (reducing slippage). Furthermore it assists in visualization of the mucosal surface. Additionally, stabilization of the endoscope during intervention by inflating the balloon to anchoring pressure can assist during therapy. Previously published clinical studies and meta-analyses have shown G-EYE® to increase adenoma detection in comparison with standard colonoscopy and other techniques

The comparative study was presented at ACG 2021 by Seth Gross, MD, Professor, Department of Medicine at NYU Grossman School of Medicine, Clinical Chief, Division of Gastroenterology and Hepatology at NYU Langone Health. Dr Gross was co-author on the abstract.

The study included 935 patients, randomized to G-EYE®– or ECV-assisted colonoscopy. Key findings from the study included:

  • Significant increase in ADR with G-EYE® over ECV (18% increase in overall ADR and 69% increase in ADR of advanced adenomas).
  • Detection of 83% more large adenomas and 87% more advanced adenomas with G-EYE® compared with ECV.

Colonoscopy is the gold standard for colorectal cancer (CRC) prevention, but folds within the colon can harbor adenomas (pre-cancerous polyps) that may not be visualized during the exam. Both G-EYE® and ECV assist colonoscopy through mechanical manipulation increasing colon surface area exposure, and have been demonstrated in prior clinical studies to increase ADR over standard colonoscopy.

Investigator comments

“The data presented at ACG 2021 demonstrate that exposing more colonic topography using the G-EYE® increased adenoma detection compared with the colonic fold manipulation provided by the ECV colonoscope attachment,” said Dr. Gross.

“Increasing the detection of adenomas, particularly advanced and large adenomas is critical for the role of colonoscopy as a CRC prevention tool.”

Source: PR Newswire

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