The large, multicenter randomized controlled clinical trial is evaluating the safety and efficacy of the ProTractX3™ TTS drug coated balloon for the treatment of benign esophageal strictures. News provided by GIE Medical via PRNewswire.
MINNEAPOLIS – GIE Medical, 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™ TTS drug coated balloon (DCB) and the first patient was enrolled at the University of North Carolina School of Medicine.
“We are excited to be testing this promising new technology,” said Nicholas J. Shaheen, MD, MPH, Chief of the UNC Division of Gastroenterology and Hepatology. “Our 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.”
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.
“We are pleased to be enrolling the randomized cohorts in PATENT-E, our treatment for esophageal stricture IDE study, and look forward to the results,” said GIE Medical Vice President Drew McClure. “We sincerely thank our clinical partners and internal GIE Medical team for achieving this significant milestone.”
People who may qualify to participate in the PATENT-E study:
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Are 22 years of age or older
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Are failing to respond to conventional dilation (have had at least one previous dilation in the past 12 months with diagnosis of stricture recurrence)
For more information about additional study requirements or to inquire about participating, visit: www.ebgcr.com or call 904-680-0871.
GIE Medical’s ProTractX3 3-Stage TTS DCB is a balloon coated with the anti-restenotic 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.