Inventive device, designed to provide permanent relief of the obstructions in patients with prostatic enlargement, will be tested in Slovakia. GCT is eager to apply and deepen our expertise in managing Urology and Medical Devices clinical trials in EU.
Benign prostatic hyperplasia (BPH) is a common condition in men 50 years and older that can be clinically observed as lower-urinary tract symptoms. There are several treatment options that include pharmacotherapy, minimally invasive therapies and surgery. The gold standard for surgical intervention has been transurethral resection of the prostate (TURP), but in recent years, as technology emerges, men tend to choose those less invasive options with fewer side-effects and morbidity. The new investigative prostate retraction device is intended to reduce most of the known side effects and complications caused by the usage of urethral stents.
Submissions to the RAs and Ethics by the local CEE team are currently underway, with the goal to start patient recruitment in early fall.