Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Smita De
Study ID
NCT07187180
Status
Recruiting
Apply to this trial

Conditions

  • BPH With Symptomatic Lower Urinary Tract Symptoms
  • BPH With Urinary Obstruction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • holmium laser — DEVICE
    Prostate enucleation will holmium laser (control)
  • pulsed thulium laser — DEVICE
    experimental group - pulsed thulium laser prostate enucleation

Study Details

Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.

Key Dates

Start date
Jun 2, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control - Holmium
    Holmium laser enucleation
  • Experimental: Experimental - Thulio
    Thulio laser enucleation

Primary Outcome Measure

Hemostasis time [ Time Frame: During surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic MainClevelandOhio44195
Iva Markovic
[email protected]
216-636-9694
Smita De, MD, PhD
[email protected]
216-445-4818

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Main· Cleveland, OH

Related Studies