N/A Completed N=209

Flexiva Pulse Registry

Urinary Calculi · Benign Prostatic Hyperplasia

Source: ClinicalTrials.gov NCT05027971 ↗

Enrolled (actual)

209

Serious AEs

4.0%

Results posted

Oct 2024

Primary outcomePrimary: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint — 2 Participants

Summary

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint	3	—
PRIMARY Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint	3	—
PRIMARY Stone Free Rates - Primary Efficacy Endpoint 1	54	—
PRIMARY Change in BPH Symptoms - Primary Efficacy Endpoint 2	-15.8	—
SECONDARY Procedure Related AEs and/or ADEs - Secondary Safety Endpoint	31	—
SECONDARY Procedure Related AEs and/or ADEs - Secondary Safety Endpoint	31	—
SECONDARY Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1	98	—
SECONDARY Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2	99	—
SECONDARY Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1	98	—
SECONDARY Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2	88	—
SECONDARY Change in Uroflowmetry - Secondary Efficacy Endpoint 2	15.0	—
SECONDARY Change in Quality of Life - Secondary Efficacy Endpoint 2	-3.4	—
SECONDARY Hemostasis - Secondary Efficacy Endpoint 2	99	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05027971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.