Flexiva Pulse Registry
Completed
Conditions studied: Urinary Calculi, Benign Prostatic Hyperplasia
In brief
To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
Key facts
- Study ID
- NCT05027971
- Run by
- Boston Scientific Corporation
- People needed
- 201
- Starts
- 2021-11-01
- Expected to finish
- 2023-10-31
- Last updated by the study team
- 2025-05-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For Lithotripsy cohort:
- Subject is undergoing treatment for urinary calculi
- Subject is willing and able to return for all follow-up visits
- For BPH cohort:
- Subject is ≥ 40 years of age
- Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- IPSS (International Prostate Symptom Score) ≥ 12
- Qmax (Peak Flow Rate) ≤ 15 mL/s
- Subject is willing and able to return for all follow-up visits
You may not qualify if…
- For Lithotripsy cohort:
- Subject has uncontrolled bleeding disorders and coagulopathy
- Subject has untreated urinary tract infection (UTI)
- Subject requires simultaneous HoLEP procedure
- For BPH cohort:
- Subject has a diagnosis of bladder cancer
- Subject has a diagnosis of prostate cancer
- Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
- Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
- Subject has urethral stricture disorder
- Subject has uncontrolled bleeding disorders and coagulopathy
- Subject has untreated urinary tract infection (UTI)
- Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
Where it is running
- Mayo Clinic Pheonix — Phoenix, Arizona, United States
- University of Miami — Miami, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Lehigh Valley Hospital — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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