Benign ProstaticHyperplasia (BPH) Clinical Trial
Official title:
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses an electro-cutting blade to perform a circular and superficial incision, in which the implant is placed. Such an implant, with the shape of an open ring, expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
The proposed study will be conducted on BPH patients, candidates for TURP and will aim to evaluate the ability of the ClearRing™ to improve BPH symptoms while conforming to safety of the procedure. In the proposed study the implants will be inserted by a dedicated delivery system with the aid of resectoscope. Electrical current will be administered by off-the-shelf CE Mark diathermy that passes through the system to cut and pave the ring course. The proper positioning of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn. The delivery tool, the implants, resectoscope and the diathermy equipment will be supplied by ProArc Ltd. ;