A study evaluating endoscopic procedure time removing complex colorectal polyps shows superiority of Lumendi’s DiLumen device over a control group.
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Connecticut-based medical device innovator Lumendi LLC reports that its 1:1 randomized trial of the DiLumen Endolumenal Interventional Platform (EIP) successfully met the primary endpoint of an IRB-approved 200-patient prospective study. The study evaluates DiLumen’s effect on endoscopic procedure time for pre-cancerous colorectal complex polypectomies. The results from an early interim analysis of data collected with 140 recruited patients demonstrates a statistically significant reduction in procedure time with DiLumen EIP against the control group (non-DiLumen), supporting successful early completion of study enrollment. There were no reportable serious adverse events during enrollment.
The DiLumen EIP is an endolumenal device with a double balloon design that aims to safely improve the navigation of the endoscope through the bowel, creates a stabilizing therapeutic zone inside the colon during endolumenal interventions, and helps minimize potential mucosal injury. Clinicians have used DiLumen in more than 1,200 procedures across the United States and Europe.
Dr. Sergey Kantsevoy, director at the Center for Therapeutic Endoscopy at Mercy Medical Center in Baltimore, conducted the IRB-approved 200-patient prospective study. “The study met our primary endpoint. The stability, improved handling properties, and dynamic retraction provided by the device contributed to this outcome,” said Dr. Kantsevoy. “The time savings will enable us to more cost-effectively and efficiently provide care to patients at our institution.”
The study’s enrollment began February 2019, and evaluates other endpoint comparators, such as safety, dissection time, dissection speed, R0 resection rates (clean pathological margins), and navigation time.
“This study will help support our assertion that DiLumen can lower the rate of unnecessary colectomies for benign adenomas and improve cost efficiency for complex colorectal polyps,” said Dr. Peter Johann, CEO of Lumendi Ltd. “These findings also support our mission to improve and revolutionize colorectal endoscopic interventions by transforming the standard of care from a traditional surgical intervention to a less-invasive procedure, utilizing an endolumenal approach that improves safety and significantly reduces costs.”
A previous 30-patient study, completed in November 2017, evaluated the ability to navigate the endoscope with the DiLumen device to the cecum (primary study endpoint), as well as the feasibility of inflating the double balloon device in both the right and sigmoid colons, creating a stable Therapeutic Zone. The study reported no significant mucosal injury requiring intervention, nor serious adverse events in any of the study patients.