Flexiva Pulse Registry

Flexiva Pulse Laser Fiber Post-Market Patient Registry

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Urinary Calculi
• Intervention / Treatment: Device: Flexiva Pulse High Power Single-Use Laser Fibers

Detailed Description

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 (Actual): 201

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Pheonix
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Approximately 200 subjects will be enrolled and treated for lithotripsy of urinary calculi and BPH indications. There will be about 100 subjects enrolled in the lithotripsy cohort and 100 subjects enrolled in the BPH cohort.

Description

Inclusion Criteria:

For Lithotripsy cohort:

1. Subject is undergoing treatment for urinary calculi
2. Subject is willing and able to return for all follow-up visits

For BPH cohort:

1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
3. IPSS (International Prostate Symptom Score) ≥ 12
4. Qmax (Peak Flow Rate) ≤ 15 mL/s
5. Subject is willing and able to return for all follow-up visits

Exclusion Criteria:

For Lithotripsy cohort:

1. Subject has uncontrolled bleeding disorders and coagulopathy
2. Subject has untreated urinary tract infection (UTI)
3. Subject requires simultaneous HoLEP procedure

For BPH cohort:

1. Subject has a diagnosis of bladder cancer
2. Subject has a diagnosis of prostate cancer
3. Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
4. Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
5. Subject has urethral stricture disorder
6. Subject has uncontrolled bleeding disorders and coagulopathy
7. Subject has untreated urinary tract infection (UTI)
8. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lithotripsy Cohort; Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi.	Device: Flexiva Pulse High Power Single-Use Laser Fibers; 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.
Benign Prostatic Hyperplasia (BPH) Cohort; 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; 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.

What is the study measuring?

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.
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
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.	1 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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	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 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.
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 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.
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.
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiber Tip Degradation - Additional Endpoint	Fiber tip degradation as measured with a three-level scale of 'Outperformed', 'Equivalent' and 'Underperformed' compared to physician's current fiber.	Through lithotripsy/HoLEP procedure completion, up to 1 day.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Prostatic Hyperplasia; Hyperplasia; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 92704912

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No