Application of MOSES Technology in BPH

NCT ID: NCT04648176

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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 using MOSES technology.

Conditions

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Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms

Keywords

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laser Holmium HoLEP Moses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HoLEP

Conventional laser

Group Type ACTIVE_COMPARATOR

Moses technology

Intervention Type DEVICE

Using Holmium laser with Moses technology or conventional one

m-HoLEP

Moses technology

Group Type EXPERIMENTAL

Moses technology

Intervention Type DEVICE

Using Holmium laser with Moses technology or conventional one

Interventions

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Moses technology

Using Holmium laser with Moses technology or conventional one

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Placer Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebrón University Hospital

Locations

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Vall d'Hebron University Hospital

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Adrià Piñero Zomeño, MD

Role: CONTACT

Phone: 934893000

Email: [email protected]

Facility Contacts

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Adrià Piñero, MD

Role: primary

Other Identifiers

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PR(AG)501/2019

Identifier Type: -

Identifier Source: org_study_id