Flexiva Pulse Registry

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Urinary Calculi Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lithotripsy Cohort

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

Flexiva Pulse High Power Single-Use Laser Fibers

Intervention Type 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

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

Flexiva Pulse High Power Single-Use Laser Fibers

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No