A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)

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A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)

Brief description of study

The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men = 45 years old, and while implanted in the prostatic urethra. The Urocross Expander Implant is indicated for an indwell duration of 6 months, after which it is retrieved under visualization, using the Urocross Retrieval Sheath and a commercially available compatible grasper used during urological procedures. The Urocross Retrieval Sheath is indicated for use to retrieve the Urocross Expander Implant using a compatible flexible cystoscope and compatible graspers commonly used during urological procedures.

Clinical Study Identifier: s22-00014

ClinicalTrials.gov Identifier: NCT05400980

Principal Investigator: Jeffrey Todd Schiff.

Other Investigator: Michelle O'Connell.

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