Flexiva Pulse Registry

NCT05027971 | Completed Results FDA Device

• 1 other identifier: 92704912
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 4

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).

Conditions

Urinary Calculi; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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

Secondary Outcomes (9)

• Procedure Related AEs and/or ADEs - Secondary Safety Endpoint

  Up to 60 days of follow-up for Lithotripsy Cohort

• Procedure Related AEs and/or ADEs - Secondary Safety Endpoint

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

• Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1

  Through lithotripsy procedure completion, up to 1 day.

• Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2

  Through HoLEP procedure completion, up to 1 day.

• Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1

  Through lithotripsy procedure completion, up to 1 day.

Study Arms (2)

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

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

Interventions

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.

Benign Prostatic Hyperplasia (BPH) Cohort; Lithotripsy Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Mayo Clinic Pheonix

Phoenix, Arizona, 85054, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Urinary Calculi; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Winnie Chen
• Organization: Boston Scientific

FlexivaPulseRegistry@bsci.com

952-930-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 31, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 29, 2025
• Results First Posted: October 26, 2024

Record last verified: 2025-05

Locations

US (4)