Flexiva Pulse Registry

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Flexiva Pulse Laser Fiber Post-Market Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027971
• Other study ID #: 92704912
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Calculi
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Calculi
• Urolithiasis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Miami	Miami	Florida
United States	AdventHealth Orlando	Orlando	Florida
United States	Mayo Clinic Pheonix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fiber Tip Degradation - Additional Endpoint	Fiber tip degradation as measured with a three-level scale of 'Outperformed', 'Equivalent' and 'Underperformed' compared to physician's current fiber.	Through lithotripsy/HoLEP procedure completion, up to 1 day.
Primary	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
Primary	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.
Primary	Stone Free Rates - Primary Efficacy Endpoint 1	In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up.	1 month follow-up
Primary	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	Procedure Related AEs and/or ADEs - Secondary Safety Endpoint	Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: Perforation: For Lithotripsy procedures: anywhere in urinary tract. For HoLEP procedures: in prostate capsule, bladder, and/or urethra; Hemorrhage resulting in blood loss of = 500mL; Burn	Up to 60 days of follow-up for Lithotripsy Cohort
Secondary	Procedure Related AEs and/or ADEs - Secondary Safety Endpoint	Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: Perforation: For Lithotripsy procedures: anywhere in urinary tract. For HoLEP procedures: in prostate capsule, bladder, and/or urethra; Hemorrhage resulting in blood loss of = 500mL; Burn	Up to 240 days of follow-up for BPH Cohort.
Secondary	Ability of fiber to deliver energy - Secondary Efficacy Endpoint 1	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.	Through lithotripsy procedure completion, up to 1 day.
Secondary	Fiber and scope compatibility - Secondary Efficacy Endpoint 1	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.	Through lithotripsy procedure completion, up to 1 day.
Secondary	Change in Quality of Life - Secondary Efficacy Endpoint 2	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.	Up to 3 month follow-up
Secondary	Change in Uroflowmetry - Secondary Efficacy Endpoint 2	For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up	Up to 3 month follow-up
Secondary	Hemostasis - Secondary Efficacy Endpoint 2	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.	Through HoLEP procedure completion, up to 1 day.
Secondary	Ability of fiber to deliver energy - Secondary Efficacy Endpoint 2	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.	Through HoLEP procedure completion, up to 1 day.
Secondary	Fiber and scope compatibility - Secondary Efficacy Endpoint 2	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.	Through HoLEP procedure completion, up to 1 day.