Richard Levin, M.D. Enrolls First Patient in VAPOR 1 IDE Study for Water Vapor Ablation of Prostate Cancer
(June 18, 2020) — Dr. Richard Levin has enrolled the first patient in Francis Medical, Inc.’s VAPOR 1 clinical study. VAPOR 1 is an early feasibility study evaluating the safety and efficacy of the company’s minimally invasive water vapor ablation therapy for the treatment of prostate cancer. Francis Medical received an investigational device exemption (IDE) for the study from the U.S. Food and Drug Administration (FDA) in late 2019.
The VAPOR 1 study will treat up to 15 patients at four U.S. clinical sites and provide initial safety and efficacy data to be used for a pivotal trial IDE with Francis Medical’s next generation device and U.S. regulatory approval. Patients in the VAPOR 1 study will be followed for up to one year, with a six-month primary endpoint for safety and efficacy outcomes.
“I am honored to have been chosen to participate in the VAPOR 1 trial for evaluating the use of water vapor to ablate cancerous prostate tissue. The use of water vapor ablation therapy has already been proven to be very efficacious with minimal side effects in treating benign prostatic hyperplasia (BPH),” said Dr. Levin. “I look forward to using this technology for treating cancerous prostate tissue and potentially lessening the likelihood of the unwanted adverse events of urinary incontinence and erectile dysfunction often associated with currently available therapies, such as radical prostate surgery and radiation.”