KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients

NCT ID: NCT02075736

Last Updated: 2024-03-06

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients

Detailed Description

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Conditions

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BPH (Benign Prostatic Hyperplasia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KTP laser

device

Group Type EXPERIMENTAL

KTP laser

Intervention Type PROCEDURE

TUR-P

device

Group Type ACTIVE_COMPARATOR

TUR-P

Intervention Type PROCEDURE

device

Interventions

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KTP laser

Intervention Type PROCEDURE

TUR-P

device

Intervention Type PROCEDURE

Other Intervention Names

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Green laser

Eligibility Criteria

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Inclusion Criteria

* Men with anticoagulant medication undergoing surgery for BPH

Exclusion Criteria

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Hannu Koistinen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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35/13/03/02/08

Identifier Type: -

Identifier Source: org_study_id

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