NCT02072499

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5.8 years

First QC Date

December 17, 2013

Last Update Submit

November 13, 2017

Conditions

BPH (Benign Prostatic Hyperplasia)

Outcome Measures

Primary Outcomes (1)

  • IPSS (International Prostate Symptom Score)

    symptom score

    12 months

Secondary Outcomes (10)

  • DAN-PSS (Danish Prostate Symptom Score)

    0, 3, 6 and 12 months

  • Maximum flow rate (Qmax)

    0, 3, 6 and 12 months

  • Residual urine

    0, 3, 6 and 12 months

  • Length of catheterization

    Participants will be followed for the duration of hospital stay, an expected maximum of two weeks

  • Length of hospital stay

    Participants will be followed for the duration of hospital stay, an expected maximum of two weeks

  • +5 more secondary outcomes

Study Arms (2)

KTP Green Light Prostatectomy

EXPERIMENTAL

Device

Procedure: KTP Green Light ProstatectomyDevice: Green Light

Open prostatectomy

ACTIVE COMPARATOR

Surgical procedure

Procedure: Open prostatectomy

Interventions

KTP Green Light ProstatectomyPROCEDURE
KTP Green Light Prostatectomy
Green LightDEVICE
KTP Green Light Prostatectomy
Open prostatectomyPROCEDURE
Open prostatectomy

Eligibility Criteria

Age40 Years - 95 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous prostate surgery
  • Carcinoma of the prostate
  • Neurogenic bladder
  • Bladder carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2013

First Posted

February 26, 2014

Study Start

September 1, 2011

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

FI(1)