NCT07187180

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2025Sep 2026

Study Start

First participant enrolled

June 2, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

June 16, 2025

Last Update Submit

September 16, 2025

Conditions

BPH With Symptomatic Lower Urinary Tract SymptomsBPH With Urinary Obstruction

Keywords

BPHEnlarged prostateThulio laserProstate enucleationmale urinary retention

Outcome Measures

Primary Outcomes (1)

  • Hemostasis time

    time required to get adequate hemostasis intraoperatively

    During surgery

Secondary Outcomes (13)

  • Blood Loss

    During surgery

  • Blood Loss

    During surgery

  • Operative parameters

    During surgery

  • Operative parameters

    During surgery

  • Operative parameters

    During surgery

  • +8 more secondary outcomes

Study Arms (2)

Control - Holmium

ACTIVE COMPARATOR

Holmium laser enucleation

Device: holmium laser

Experimental - Thulio

EXPERIMENTAL

Thulio laser enucleation

Device: pulsed thulium laser

Interventions

holmium laserDEVICE

Prostate enucleation will holmium laser (control)

Control - Holmium
pulsed thulium laserDEVICE

experimental group - pulsed thulium laser prostate enucleation

Experimental - Thulio

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and voluntarily sign an informed consent form.
  • Patients must be males with a prostate, at least 18 years of age
  • No prior prostate surgery

You may not qualify if:

  • Unable/refuse to provide informed consent
  • Prior prostate surgery
  • Bladder stones that requiring lasering (small stone that can be removed whole is ok)
  • Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Iva Markovic

CONTACT

216-636-9694markovi@ccf.org

Smita De, MD, PHD

CONTACT

216-445-4818des@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2025

First Posted

September 22, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

US(1)