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 study is a pivotal, prospective, multi-center, randomized, sham-controlled, blinded clinical trial to evaluate the safety and efficacy of the Urocross Expander System and Retrieval Sheath. Male subjects of 45 years or older suffering from symptomatic benign prostatic hyperplasia (BPH) and willing to stop their BPH medication will be recruited.
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.


Clinical Study Identifier: s22-00014
ClinicalTrials.gov Identifier: NCT05400980
Principal Investigator: Jeffrey Todd Schiff.
Other Investigator: Michelle O'Connell.


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