Flexiva Pulse Registry

Completed

• Conditions: Urinary Calculi; Benign Prostatic Hyperplasia
• Interventions: Device: Flexiva Pulse High Power Single-Use Laser Fibers

• Registration Number: NCT05027971
• Lead Sponsor: Boston Scientific Corporation

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).

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 Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Study Start: 2021-11-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Results First Submitted: 2024-07-31
• Results First Submitted QC: 2024-07-31
• Results First Posted: 2024-10-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign Prostatic Hyperplasia (BPH) Cohort	Flexiva Pulse High Power Single-Use Laser Fibers	Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH.
Lithotripsy Cohort	Flexiva Pulse High Power Single-Use Laser Fibers	Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi.

Primary Outcome Measures

Name	Time	Method
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. 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.
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

Name	Time	Method
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 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.
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 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.
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.
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
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.
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.

Trial Locations

Locations (4)

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