Flexiva Pulse Registry
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint [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.
- Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint [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.
- Stone Free Rates - Primary Efficacy Endpoint 1 [1 month follow-up]
In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up.
- Change in BPH Symptoms - Primary Efficacy Endpoint 2 [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 Outcome Measures
- Procedure Related AEs and/or ADEs - Secondary Safety Endpoint [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. For HoLEP procedures: in prostate capsule, bladder, and/or urethra Hemorrhage resulting in blood loss of ≥ 500mL Burn
- Procedure Related AEs and/or ADEs - Secondary Safety Endpoint [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 Lithotripsy procedures: anywhere in urinary tract. For HoLEP procedures: in prostate capsule, bladder, and/or urethra Hemorrhage resulting in blood loss of ≥ 500mL Burn
- Ability of fiber to deliver energy - Secondary Efficacy Endpoint 1 [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.
- Fiber and scope compatibility - Secondary Efficacy Endpoint 1 [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.
- Change in Quality of Life - Secondary Efficacy Endpoint 2 [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.
- Change in Uroflowmetry - Secondary Efficacy Endpoint 2 [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
- Hemostasis - Secondary Efficacy Endpoint 2 [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.
- Ability of fiber to deliver energy - Secondary Efficacy Endpoint 2 [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.
- Fiber and scope compatibility - Secondary Efficacy Endpoint 2 [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.
Other Outcome Measures
- Fiber Tip Degradation - Additional Endpoint [Through lithotripsy/HoLEP procedure completion, up to 1 day.]
Fiber tip degradation as measured with a three-level scale of 'Outperformed', 'Equivalent' and 'Underperformed' compared to physician's current fiber.
Eligibility Criteria
Criteria
Inclusion Criteria:
For Lithotripsy cohort:
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Subject is undergoing treatment for urinary calculi
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Subject is willing and able to return for all follow-up visits
For BPH cohort:
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Subject is ≥ 40 years of age
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Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
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IPSS (International Prostate Symptom Score) ≥ 12
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Qmax (Peak Flow Rate) ≤ 15 mL/s
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Subject is willing and able to return for all follow-up visits
Exclusion Criteria:
For Lithotripsy cohort:
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Subject has uncontrolled bleeding disorders and coagulopathy
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Subject has untreated urinary tract infection (UTI)
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Subject requires simultaneous HoLEP procedure
For BPH cohort:
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Subject has a diagnosis of bladder cancer
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Subject has a diagnosis of prostate cancer
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Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
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Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
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Subject has urethral stricture disorder
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Subject has uncontrolled bleeding disorders and coagulopathy
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Subject has untreated urinary tract infection (UTI)
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Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
| 2 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 3 | Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18103 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 92704912