NCT04648176

Brief Summary

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 6, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

March 6, 2020

Last Update Submit

November 27, 2020

Conditions

Benign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms

Keywords

laserHolmiumHoLEPMoses

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    Hemoglobin change

    24 hours after the surgery

Secondary Outcomes (9)

  • Enucleation time

    during the surgery

  • Hemostasis time

    during the surgery

  • Morcellating time

    during the surgery

  • Surgery time

    during the surgery

  • Irrigated volume of serum

    during the surgery

  • +4 more secondary outcomes

Study Arms (2)

HoLEP

ACTIVE COMPARATOR

Conventional laser

Device: Moses technology

m-HoLEP

EXPERIMENTAL

Moses technology

Device: Moses technology

Interventions

Moses technologyDEVICE

Using Holmium laser with Moses technology or conventional one

HoLEPm-HoLEP

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostatic volume between 70-200cc
  • Acceptance to participate in the study.

You may not qualify if:

  • Previous urethra stricture
  • Previous prostate surgery
  • Neurogenic bladder
  • Bladder tumor
  • Neurological disease with repercussion in the lower urinary tract.
  • Severe psychiatric illness
  • Inability of the patient to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José Placer Santos, PhD

    Vall d'Hebrón University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrià Piñero Zomeño, MD

CONTACT

934893000adria.pinero@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

December 1, 2020

Study Start

March 6, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)