NCT05027971

Flexiva Pulse Registry

Flexiva Pulse Laser Fiber Post-Market Patient Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Calculi
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-08-31
• Last updated: 2025-05-29
• Results posted: 2024-10-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study