NCT04514718

Brief Summary

The purpose of this study is to prove that low-energy (30W) Holmium laser prostatectomy (Holeb) is not inferior to high-energy (100W) Holmium laser prostatectomy (safety and effectiveness)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 13, 2020

Last Update Submit

August 13, 2020

Conditions

Prostate HyperplasiaProstatic HypertrophySurgeryBladder Outlet ObstructionQuality of LifeComplication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

  • IPSS total score

    International Prostate Symptom Score

    baseline, postoperative 3 months, and 6 months

Secondary Outcomes (3)

  • surgery time, total energy, resected prostate volume, immediate complication

    Surgery day

  • IPSS-subscore, IPSS-QoL, OABSS total score

    baseline, postoperative 3 months, and 6 months

  • Qmax, post voided residual urine volume

    baseline, postoperative 3 months, and 6 months

Study Arms (2)

low energy holmium laser

ACTIVE COMPARATOR

30 watts

Device: Holmium laser

high energy holmium laser

ACTIVE COMPARATOR

80-100 watts

Device: Holmium laser

Interventions

Holmium laserDEVICE

low energy holmium laser

high energy holmium laserlow energy holmium laser

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Bladder Neck Obstruction

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

August 24, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share