Studies: Neptune Medical’s Pathfinder Endoscope Overtube Improves Patient Outcomes

New study data show Neptune Medical’s Pathfinder Endoscope Overtube significantly improves endoscope control and completion of difficult upper and lower endoscopic procedures.

Colonic endoscopic submucosal dissection (ESD) can be challenging for many GIs due to the anatomy’s unique configuration, but it has been shown to achieve higher rates of en block and R0 resection leading to a higher curative resection rate. With this in mind, investigators with varying ESD expertise from Baylor St. Luke’s Medical Center, Texas, initiated a prospective, single-center, post-market, randomized controlled trial in 46 patients to study the ability of the Pathfinder device to enhance ESD when compared to conventional ESD in patients requiring advanced polyp resection.

According to interim study results, all ESD procedures facilitated with the Pathfinder device were completed. The Pathfinder-enabled procedures demonstrated dramatically improved scope stability (72.7% vs. 20.8% n= <0.001) and retroflexion ability (94.7% vs. 47.4%; n=0.001) when compared to conventional ESD.

“In this study, the novel rigidizing overtube facilitated colonic ESD by improving endoscope stability and control without compromising outcomes compared to conventional ESD. The Pathfinder procedure made ESD achievable and successful for all three of our investigators, despite varying experience levels with the procedure. There is also a trend towards higher procedure speed with the use of the overtube,” said Mohamed Othman, M.D., chief of Gastroenterology at Baylor St. Luke’s Medical Center, Texas, and principal study investigator. Co-principal investigators included Tara Keihanian, M.D., and Salmaan Jawaid, M.D., also with Baylor.

A second study—a retrospective multicenter trial performed at the University of South Florida and Cleveland Clinic Florida—examined the Pathfinder’s ability to enable complete endoscopic procedures across looping colon, deep enteroscopy, and endoscopic retrograde cholangiopancreatography (ERCP) in 42 adult patients.

In a patient population where 71% of patients had previously had incomplete endoscopic procedures, interim results from the study showed the Pathfinder device facilitated a 97% completion rate and 100% technical success in these challenging procedures, with no device-related adverse events.

“In this first multicenter study of the Pathfinder rigidizing overtube, we found that the device was safe and enabled high technical and clinical success rates in endoscopic procedures technically challenged by looping, redundant/tortuous colons, and surgically altered anatomy. In addition, the device facilitated completion of a prior incomplete endoscopy,” said Pushpak Taunk, M.D., associate professor of Medicine, director of Advanced Endoscopy Fellowship with the University of South Florida’s Division of Digestive Disease and Nutrition, and senior study author.

The Pathfinder Endoscope Overtube is designed to manage loop formation, easily navigate tortuous anatomy, and control the scope tip for various diagnostic and therapeutic GI procedures. Its unique ability to instantly toggle from flexible to rigid, and back again, creates a stable platform for retroflex RO resections, with no loss of position, offering greater control to operators of all skill levels.

“These studies validate that our Pathfinder technology safely enhances stability and control for GIs with varied skill levels, even across the most challenging procedures,” Neptune Medical Founder/CEO Alex Tilson stated. “We believe this evidence supports universal use of the device in difficult endoscopic procedures to improve completion rates, which would speed treatment, improve patient outcomes, and potentially improve healthcare costs associated with failed colonoscopy.”

Neptune Medical develops advanced medical devices, focusing primarily on gastrointestinal robotics. The company’s mission is to enhance patient outcomes through innovative technology and collaborative partnerships.