Active, currently enrolling
The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath
NCT No.: NCT05400980
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym:
Official Title
The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath
Purpose
To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH)
Detailed Description
Eligibility Criteria
Inclusion Criteria
- Subject has signed an informed consent form (ICF).
Men = 45 years.
Symptomatic BPH with the following (all must be met):
IPSS = 13.
Qmax = 12 mL/sec on a voided volume of = 125 mL.
PVR < 250 mL.
Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation.
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Exclusion Criteria
- Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
High bladder neck as determined by the Investigator.
Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
Biopsy of the prostate within past 8 weeks.
Baseline Prostate Specific Antigen (PSA) level > 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level > 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making [SDM] with the study subjects).
Confirmed or suspected bladder cancer.
History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
History of neurogenic bladder.
Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
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Keywords and/or Specific Medical Conditions
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- Surgery (Colon and Rectal)
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Sponsors
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