WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has announced the enrollment of the first patient in a new clinical study focused on the Barrigel™ rectal spacer. This major milestone marks the beginning of a randomized, controlled, single-blinded multicenter study named the PPRT Trial. The study will evaluate the effectiveness of the Barrigel™ rectal spacer in patients undergoing hypofractionated post-prostatectomy radiation therapy.
Barrigel™ stands out as the only sculptable hyaluronic acid rectal spacer designed to minimize radiation exposure to the rectum during prostate cancer treatment. This innovative approach is crucial in hypofractionated regimens, where higher radiation doses are administered over fewer sessions. The unique composition of Barrigel™ allows it to remain soft and pliable, providing physicians with the flexibility to shape it for optimal rectal protection during treatment.
Dr. Martin T. King, a Radiation Oncologist at Dana-Farber Brigham Cancer Center and principal investigator of the study, emphasized the importance of this development. He noted the potential of Barrigel™ to offer a safe and effective solution for reducing radiation side effects in prostate cancer patients who have previously undergone prostatectomy.
The study will involve several sites in the U.S. and one in Australia. Participating patients have previously undergone nerve-sparing prostatectomy and must show no evidence of metastatic disease. The trial aims to solidify Barrigel™ as a reliable option for improving patient outcomes in prostate radiation therapy.
Dr. Michael Chao, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Australia, is proud to be the first to treat a patient with Barrigel™ in this clinical trial. He highlighted the significance of scientific evidence in advancing medical technologies and building trust between clinicians and patients.
Barrigel™ has already demonstrated its ability to reduce unwanted side effects of prostate cancer radiation therapy and is approved for use in the U.S., Australia, and Europe. It is suitable for patients with T1-T3b prostate cancer, further expanding its potential impact on patient care worldwide.
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