Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today the enrollment of the first patient in a pilot study of the Pure-Vu® System. The study is evaluating the clinical and economic outcomes using the Pure-Vu System in patients with emergent lower gastrointestinal bleeding that are evaluated and treated in the Intensive Care Unit (ICU) or the rapid inpatient endoscopy suite.
The study, which is being conducted at a leading a non-profit, academic medical center in the U.S., is expected to enroll up to 20 patients with acute lower GI bleeding, who are undergoing urgent colonoscopy under monitored anesthesia care or conscious sedation. The colonoscopies will be performed using the Pure-Vu System after the patient has received minimal to no purgative preparation and two enemas. Cleansing success will be attained if a Boston Bowel Preparation Scale (BBPS) of ≥2 is achieved in all three colonic segments. The primary outcome of the study will be the proportion of patients who achieve an adequate bowel preparation to identify bleeding lesions in all three colonic segments. Additional information on the study is available at ClinicalTrials.gov (click here).
"We are excited to work with a well-known U.S. medical institution to evaluate how the Pure-Vu System may be able to improve the clinical and economic outcomes for patients with lower gastrointestinal bleeding. In addition, this study is designed for patients to undergo minimal bowel prep – just two enemas over a 30-minute period – with a goal of providing patients a much faster diagnosis as compared to the 24-hours usually required to do a full bowel prep," said Tim Moran, chief executive officer of Motus GI. "This study builds upon a number of patient case studies presented to us over the past year that show how treating physicians were able to rapidly diagnose and treat bleeds in patients due to the improved visualization the Pure-Vu System provides during colonoscopy."
In May 2019, the U.S. Food and Drug Administration (FDA) issued 510(k) clearance for the Pure-Vu GEN2 System. The system is approved to connect to standard or slim colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.