{"id":66313,"date":"2023-12-13T07:27:21","date_gmt":"2023-12-13T12:27:21","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?p=66313"},"modified":"2023-12-12T13:35:01","modified_gmt":"2023-12-12T18:35:01","slug":"gie-medical-announces-first-patient-enrolled-in-patent-e-benign-esophageal-stricture-treatment-study","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/medicine\/news\/gie-medical-announces-first-patient-enrolled-in-patent-e-benign-esophageal-stricture-treatment-study\/","title":{"rendered":"GIE Medical Announces First Patient Enrolled in PATENT-E Benign Esophageal Stricture Treatment Study"},"content":{"rendered":"

The large, multicenter randomized controlled clinical trial is evaluating the safety and efficacy of the ProTractX3\u2122 TTS drug coated balloon for the treatment of benign esophageal strictures. News provided by GIE Medical\u00a0<\/a>via PRNewswire.<\/a><\/em><\/p>\n

\n

MINNEAPOLIS \u2013 GIE Medical<\/a>, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, announced today that enrollment has begun in its Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture – Esophagus (PATENT-E) study. The study is evaluating the safety and efficacy of the first of its kind ProTractX3\u2122 TTS drug coated balloon (DCB) and the first patient was enrolled at the University of North Carolina School of Medicine.<\/span><\/p>\n

\"\"
Dr. Nicholas J. Shaheen<\/figcaption><\/figure>\n

\u201cWe are excited to be testing this promising new technology,\u201d said Nicholas J. Shaheen, MD, MPH, Chief of the UNC Division of Gastroenterology and Hepatology. \u201cOur patients with difficult-to-treat strictures need treatment options that are effective and safe. We hope to show that this innovative approach provides a new direction for them.\u201d<\/span><\/p>\n

Earlier this year, the Food and Drug Administration Center for Devices and Radiological Health (CDRH) granted GIE Medical the Breakthrough Device Designation to expedite development of its ProTractX3 TTS DCB for patient access because it has a reasonable chance of providing more effective treatment of life-threatening or irreversibly debilitating human disease or conditions than the current standard of care.<\/span><\/p>\n

\u201cWe are pleased to be enrolling the randomized cohorts in PATENT-E, our treatment for esophageal stricture IDE study, and look forward to the results,\u201d said GIE Medical Vice President Drew McClure. \u201cWe sincerely thank our clinical partners and internal GIE Medical team for achieving this significant milestone.\u201d<\/span><\/p>\n

People who may qualify to participate in the PATENT-E study:<\/span><\/p>\n