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).
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.
Study Type
OBSERVATIONAL
Enrollment
201
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.
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
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.
Time frame: 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.
Time frame: 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. Stone free was defined as clinically nonsignificant, non-obstructive residual fragments of ≤ 3 mm, asymptomatic, and no auxiliary procedures performed between the final Flexiva Pulse holmium laser lithotripsy procedure and the 1-month follow-up.
Time frame: 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.
Time frame: 3 month follow-up
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. * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
Time frame: Up to 60 days of follow-up for Lithotripsy Cohort
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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 HoLEP procedures: in prostate capsule, bladder, and/or urethra * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
Time frame: 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.
Time frame: Through lithotripsy 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.
Time frame: Through HoLEP 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.
Time frame: Through lithotripsy 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.
Time frame: Through HoLEP procedure completion, up to 1 day.
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
Time frame: Up to 3 month follow-up
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.
Time frame: 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.
Time frame: Through HoLEP procedure completion, up to 1 day.