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KTP Green Light Prostatectomy Compared With Open Prostatectomy

NCT ID: NCT02072499

Last Updated: 2017-11-14

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-10-31

Brief Summary

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The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).

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 Green Light Prostatectomy

Device

Group Type EXPERIMENTAL

KTP Green Light Prostatectomy

Intervention Type PROCEDURE

Green Light

Intervention Type DEVICE

Open prostatectomy

Surgical procedure

Group Type ACTIVE_COMPARATOR

Open prostatectomy

Intervention Type PROCEDURE

Interventions

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KTP Green Light Prostatectomy

Intervention Type PROCEDURE

Green Light

Intervention Type DEVICE

Open prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men undergoing surgery for BPH with prostate size more than 100cc

Exclusion Criteria

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

40 Years

Maximum Eligible Age

95 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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164/13/03/02/08

Identifier Type: -

Identifier Source: org_study_id