ALPFA GRAIL PFA System for Enlarged Prostate

(REBOUND Trial)

This trial aims to evaluate the effectiveness of the ALPFA GRAIL Pulsed Field Ablation (PFA) System in treating symptoms of an enlarged prostate, also known as BPH. Participants will receive either the PFA treatment or a sham procedure, which mimics treatment without therapeutic effect, to compare outcomes. Men experiencing urinary problems due to BPH and who have not undergone prostate surgery may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future treatments for BPH.

Research has shown that the ALPFA GRAIL Pulsed Field Ablation (PFA) System is generally well-tolerated. Studies of similar systems using pulsed field ablation reported a low complication rate, with issues in about 2.23% of cases, indicating a high level of safety.

One study found that pulsed electromagnetic fields, related to this technology, reduced prostate size by an average of 27.3% without side effects, highlighting the treatment's potential for safety and effectiveness.

Researchers are excited about the ALPFA GRAIL Pulsed Field Ablation (PFA) System because it offers a novel approach to treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Unlike traditional treatments like medications or surgical procedures that involve cutting or heating tissues, the PFA system uses electrical pulses to precisely target and ablate prostate tissue. This method aims to reduce risks associated with more invasive surgeries and potentially leads to quicker recovery times. By minimizing damage to surrounding tissues, the ALPFA GRAIL PFA System could offer a safer and more efficient option for patients with BPH.

Research has shown that the ALPFA GRAIL Pulsed Field Ablation System aims to alleviate symptoms of an enlarged prostate (BPH) by using targeted electrical energy. This method avoids heat and instead reshapes prostate tissue. Early studies indicate that it can improve urine flow and increase the maximum flow rate (Qmax), which measures how quickly urine can be passed. Importantly, it appears to preserve ejaculatory function, a common concern with prostate treatments. These initial findings suggest the treatment may effectively reduce symptoms for men with BPH. Participants in this trial will be randomly assigned to receive either the ALPFA GRAIL Pulsed Field Ablation System or a sham procedure, with some having the option to crossover to the treatment after initial assessments.⁶⁷⁸⁹¹⁰