Clinical trial NCT05027971: Flexiva Pulse Registry
Official title: Flexiva Pulse Laser Fiber Post-Market Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Calculi
Benign Prostatic Hyperplasia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
timeFrame: Up to 60 days of follow-up for Lithotripsy Cohort
measure: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
timeFrame: Up to 240 days of follow-up for BPH Cohort.
measure: Stone Free Rates - Primary Efficacy Endpoint 1
timeFrame: 1 month follow-up
measure: Change in BPH Symptoms - Primary Efficacy Endpoint 2
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
timeFrame: Up to 60 days of follow-up for Lithotripsy Cohort
measure: Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
timeFrame: Up to 240 days of follow-up for BPH Cohort.
measure: Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1
timeFrame: Through lithotripsy procedure completion, up to 1 day.
measure: Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2
timeFrame: Through HoLEP procedure completion, up to 1 day.
measure: Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1
timeFrame: Through lithotripsy procedure completion, up to 1 day.
measure: Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2
timeFrame: Through HoLEP procedure completion, up to 1 day.
measure: Change in Uroflowmetry - Secondary Efficacy Endpoint 2
timeFrame: Up to 3 month follow-up
measure: Change in Quality of Life - Secondary Efficacy Endpoint 2
timeFrame: Up to 3 month follow-up
measure: Hemostasis - Secondary Efficacy Endpoint 2
timeFrame: Through HoLEP procedure completion, up to 1 day.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Pheonix
state: Arizona
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
Study officials:
References: