Study for BPH

Rebound Study for BPH

The Rebound Study

This Study is a prospective pivotal clinical study to assess the safety and effectiveness of the ALPFA GRAIL PFA System in the treatment of men over the age of 45 with lower urinary tract symptoms associated with BPH.

A New Option

The ALPFA GRAIL solution was developed to minimize post-procedure complications and ease the concerns patients often face when considering BPH treatment, particularly those involving urinary or sexual function.

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The ALPFA GRAIL catheter is inserted into the prostatic urethra, with the lead balloon inflated near the bladder neck to stabilize and position the device.

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The remaining balloon(s) are then deployed and inflated. Two or three balloons are used to adapt to each patient’s prostate length.

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The console delivers engineered electrical waveforms through the braided electrodes, creating a controlled and precise pulsed electric field that extends beyond the urethra to reach nearly all of the prostate tissue.

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The pulsed field targets prostate cells while sparing surrounding structures like the urethral wall and sperm ducts, enabling a safe, tissue-selective approach to prostate ablation.

Watch ALPFA GRAIL video

Eligibility for the REBOUND Study

The REBOUND Study is for men 45 and older with symptomatic benign prostatic hyperplasia. Study timing and detailed eligibility requirements will be confirmed.

You may qualify for the REBOUND Study if you meet the following criteria*:

1. 45+ years of age on the day of enrollment.

2. Symptomatic BPH (baseline IPSS score ≥ 13 determined within 30 days preceding enrollment) and after fulfilling the concomitant medication washout period(s):

3. Prostate size 25-150 g, measured by transrectal ultrasound.

4. Willing and able to provide consent and comply with study requirements.

*Please note that other requirements will apply. Contact your physician to discuss the REBOUND Study.

Trial locations

For more information about The REBOUND Study, including sites where enrollment is active, please CLICK HERE.- GOES TO GALEN SITE link pending.

Indications & potential risks

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.The ALPFA GRAIL Pulsed Field Ablation (PFA) System is being studied for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) in the REBOUND Study.

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