Flexiva Pulse Registry

Study Overview
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Brief Summary
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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).

Detailed Description
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Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers. All subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/HoLEP procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from HoLEP procedure for subjects in the Benign Prostatic Hyperplasia (BPH) cohort.

Official Title
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Flexiva Pulse Laser Fiber Post-Market Patient Registry

Conditions
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Urinary Calculi, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Flexiva Pulse High Power Single-Use Laser Fibers


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lithotripsy Cohort<br>Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. | Device: Flexiva Pulse High Power Single-Use Laser Fibers<br>* Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy.<br>|
| Benign Prostatic Hyperplasia (BPH) Cohort<br>Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. | Device: Flexiva Pulse High Power Single-Use Laser Fibers<br>* Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures. | Up to 60 days of follow-up for Lithotripsy Cohort | 
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures. | Up to 240 days of follow-up for BPH Cohort. | 
| Stone Free Rates - Primary Efficacy Endpoint 1 | In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up. | 1 month follow-up | 
| Change in BPH Symptoms - Primary Efficacy Endpoint 2 | In HoLEP procedures: Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3 month follow-up, on a scale of 0 to 35. | 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: Perforation: For Lithotripsy procedures: anywhere in urinary tract. For HoLEP procedures: in prostate capsule, bladder, and/or urethra Hemorrhage resulting in blood loss of ≥ 500mL Burn | Up to 60 days of follow-up for Lithotripsy Cohort | 
| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: Perforation: For Lithotripsy procedures: anywhere in urinary tract. For HoLEP procedures: in prostate capsule, bladder, and/or urethra Hemorrhage resulting in blood loss of ≥ 500mL Burn | Up to 240 days of follow-up for BPH Cohort. | 
| Ability of fiber to deliver energy - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Ability of the laser fiber to deliver energy as measured by whether or not the Lithotripsy procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Through lithotripsy procedure completion, up to 1 day. | 
| Fiber and scope compatibility - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Through lithotripsy procedure completion, up to 1 day. | 
| Change in Quality of Life - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Improvement in Quality of Life (QoL) from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3-month follow-up, on a scale of 0 to 6. | Up to 3 month follow-up | 
| Change in Uroflowmetry - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up | Up to 3 month follow-up | 
| Hemostasis - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Hemostasis measured by ability to coagulate during HoLEP procedure. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. | 
| Ability of fiber to deliver energy - Secondary Efficacy Endpoint 2 | For HoLEP procedures: Ability of the laser fiber to deliver energy as measured by whether or not the HoLEP procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. | 
| Fiber and scope compatibility - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. |