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Completed

NCT Number: NCT05027971

Flexiva Pulse 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).

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Key information

Conditions

Urinary Calculi Benign Prostatic Hyperplasia Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases Urolithiasis Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Pheonix, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flexiva Pulse High Power Single-Use Laser Fibers

Device

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.

Primary outcomes

  1. Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint

    Time frame: Up to 60 days of follow-up for Lithotripsy Cohort

    The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.

  2. Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint

    Time frame: Up to 240 days of follow-up for BPH Cohort.

    The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.

  3. Stone Free Rates - Primary Efficacy Endpoint 1

    Time frame: 1 month follow-up

    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.

  4. Change in BPH Symptoms - Primary Efficacy Endpoint 2

    Time frame: 3 month follow-up

    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.

Secondary outcomes

  1. Procedure Related AEs and/or ADEs - Secondary Safety Endpoint

    Time frame: Up to 60 days of follow-up for Lithotripsy Cohort

    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

  2. Procedure Related AEs and/or ADEs - Secondary Safety Endpoint

    Time frame: Up to 240 days of follow-up for BPH Cohort.

    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

  3. Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1

    Time frame: Through lithotripsy procedure completion, up to 1 day.

    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.

  4. Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2

    Time frame: Through HoLEP procedure completion, up to 1 day.

    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.

  5. Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1

    Time frame: Through lithotripsy procedure completion, up to 1 day.

    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.

  6. Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2

    Time frame: Through HoLEP procedure completion, up to 1 day.

    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.

  7. Change in Uroflowmetry - Secondary Efficacy Endpoint 2

    Time frame: Up to 3 month follow-up

    For HoLEP procedures:

    • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up

  8. Change in Quality of Life - Secondary Efficacy Endpoint 2

    Time frame: Up to 3 month follow-up

    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.

  9. Hemostasis - Secondary Efficacy Endpoint 2

    Time frame: Through HoLEP procedure completion, up to 1 day.

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Flexiva Pulse Laser Fiber Post-Market Patient Registry

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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