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Flexiva Pulse Registry

NCT05027971 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2025-05-29

Study results available
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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).

Conditions

  • Urinary Calculi
  • Benign Prostatic Hyperplasia

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027971 on ClinicalTrials.gov