At a glance
ClinicalIndex Comparison RecordN/ACompleted· 201 enrolled
Drug / intervention
Flexiva Pulse High Power Single-Use Laser Fibersdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Flexiva Pulse Laser Fiber Post-Market Patient Registry
In Brief
An observational study evaluating Flexiva Pulse High Power Single-Use Laser Fibers for Urinary Calculi and Benign Prostatic Hyperplasia. Completed, enrolled 201 participants across 4 sites.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Calculi, Benign Prostatic Hyperplasia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartNov 2021
Primary CompletionOct 2023
TodayJul 2026
First PostedAug 31, 2021
Enrollment StartNov 1, 2021
Primary CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 4.8 years ago
Interventions
Flexiva Pulse High Power Single-Use Laser Fibersdevice
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.