Lumendi has completed enrollment of a first-in-human trial of its DiLumen EIP technology, meeting the study’s primary endpoint.
There were no serious adverse events in any of the study patients.
The observational registry study of 30 patients was a single-center functional and safety evaluation of the DiLumen with two investigators during routine colonoscopy. The device received FDA 510K clearance to market in December 2016. The study was initiated in late April 2017.
The study evaluated the ability to navigate the scope 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™ (TZ). There was no significant mucosal injury (primary safety endpoint) that required intervention in any patient.
The institutional sponsor is Weill Cornell Medicine in New York City. The primary population for all efficacy and safety summaries are patients who undergo colonoscopy, with a safety population sub-group of patients who undergo therapeutic intervention during the colonoscopy procedure. A manuscript reporting all study outcomes is currently in development.
“These findings support our aim to improve endoscopic interventions and revolutionize colorectal surgery by transforming the paradigm from the traditional surgical approach to a truly minimally invasive one utilizing novel endolumenal-based technology, increasing safety and significantly reducing costs,” said Dr. Peter Johann, CEO of Lumendi, Ltd.
Dr. Reem Sharaiha, director of bariatric endoscopy and associate director of the Pancreas Program at NewYork-Presbyterian/Weill Cornell Medical Center, an assistant professor of medicine at Weill Cornell Medicine and lead investigator, remarked: “The device appears very safe and the TZ can reliably be created in both the right and left colon. I see the value in the double balloon system to help facilitate and broaden less invasive therapeutic options to treat colonic disease.”
The DiLumen Endolumenal Interventional Platform (EIP) is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine and facilitates use of the endoscope for optical visualization, diagnosis, and treatment.
The device was developed by Lumendi in collaboration with the Minimally Invasive New Technologies Program (MINT) at Weill Cornell Medicine and NewYork-Presbyterian. It is the first device from the Endolumenal Interventional Platform based on Lumendi and MINT’s initiative to migrate many gastrointestinal surgeries to endolumenal procedures.