Plymouth, MN, Dec. 13, 2022 (GLOBE NEWSWIRE) -- GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, has launched two large, multicenter randomized controlled clinical trials in the United States to investigate the company’s first of its kind multi-stage drug-coated balloon (DCB) technology, ProTractX3™ TTS DCB.
The first trial, PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture - Esophagus (PATENT-E), is a study to evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures. Patients will be randomized to receive the ProTractX3™ DCB or standard-of-care endoscopic dilation. The study will compare the number of patients with improvement of dysphagia symptoms without clinically driven repeat intervention between arms at 6-months post treatment, as well as compare the rate of treatment-related major adverse events through 30-days post treatment.
The second, PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture - Bowel (PATENT-B), is a study to evaluate the safety and efficacy of ProTractX3™ DCB for the treatment of benign bowel strictures. Patients will be randomized to receive the ProTractX3™ DCB or standard-of-care endoscopic dilation. The study will compare the rate of anatomic success between arms at 6-months post-treatment, as measured by the ability to pass a pediatric colonoscope through the treated area without significant resistance. The rate of treatment-related major adverse events will be compared between arms at 30-days post treatment.
Several patients have already been treated in these trials, and active enrollment will continue throughout the U.S.
Professor Emeritus Dr. Kenneth Wang M.D. with The Mayo Clinic Rochester said of the technology, “We are hopeful that this will represent a new method of providing relief for these patients who have been dealing with chronic difficulty swallowing.”
GIE Medical Chief Operating Officer, Peter Barnett said, “This technology could truly impact patient care and quality of life, and our initial use cases mark the first time this groundbreaking technology has been used in the United States.”
GIE Medical’s ProTractX3™ 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. It is an investigational device in the U.S.
ABOUT GIE MEDICAL:
GIE Medical is a clinical stage company conducting trials in the U.S. to help patients suffering from benign stricture(s) of the esophagus or bowel (small intestine, colon, and rectum).
The ProTractX3™ Through the Scope Drug Coated Balloon could offer a new solution for treating GI strictures, potentially creating sustained long-term patency and reducing the number of treatments. For more information, visit www.GIEMedical.com.
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