Flexiva Pulse Registry

Boston Scientific

Status: Completed

Conditions: Benign Prostatic Hyperplasia; Urinary Calculi

Treatments: Device: Flexiva Pulse High Power Single-Use Laser Fibers

Study type: Observational

Funder types: Industry

Identifiers

NCT05027971

92704912

Details and patient eligibility

About

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).

Full 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.

Enrollment: 201 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

201 participants in 2 patient groups

Lithotripsy Cohort

Description:

Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi.

Treatment:

Device: Flexiva Pulse High Power Single-Use Laser Fibers

Benign Prostatic Hyperplasia (BPH) Cohort

Description:

Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH.

Treatment:

Device: Flexiva Pulse High Power Single-Use Laser Fibers