|
| Overall Recruitment Status: Active, currently enrolling |
| |
| Official Title |
| Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross(TM) Expander System & Retrieval Sheath |
| |
| Region |
Sponsors |
| California - Northern |
|
| |
| Acronym |
KP IRB No. |
|
45663160 |
| |
| Study Type |
Phase |
| Prospective Cohort Study with Direct Patient Contact |
|
| |
| Study Population Description |
|
| |
| 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 |
|
| |
| Gender |
Age Limit |
| Male & Female |
|
| |
- 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.
Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.
|
- Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
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.
|
|
| |
|
|
| |
|