Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

NACompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions
Benign Prostatic Hyperplasia
Interventions
DEVICE

Photoselective Vaporization of the Prostate

"GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.~GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator."

DEVICE

Transurethral Resection of the Prostate

Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.

Trial Locations (29)

69120

University Hospital of Heidelberg, Heidelberg

Unknown

Krankenhaus der Barmherzigen Schwestern Linz, Linz

AZ Maria Middelares Gent, Ghent

Nouvel Hopital Civil de Strasbourg, Strasbourg

CHU Bretonneau, Tours

Campus Bejamin Franklin Hindenburgdamm, Berlin

UroForshungs GmbH, im St. hedwig Krankenhaus, Berlin

Krankenhaus Nordwest, Frankfurt

Hospital University of Jena, Jena

Universitatsklinikum Schleswig-Holstein, Campus Kiel, Kiel

Universitatsklinikum Leipzig, Leipzig

Universitatsklinikum Magdeburg, Magdeburg

Diakoniekrankenhaus Rotenburg (W.) gGmbH, Rotenburg (Wümme)

Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital, Rome

ZGT Almelo, Almelo

Hospital Iniversitario Fundacion Alcorcon, Madrid

Hospital de Manacor, Manacor

University of Basel, Basel

Mid Yorkshire NHS Trust Dewsbury & District Hospital, Dewsbury

Kent and Canterbury Hospital, Kent

Whipps Cross University Hospital, London

Freeman Hospital, Newcastle

6500 HB Nijmegen

RadBound University Njmegen Medical Centre, Nijmegen

GU16 7UJ- UK

Frimley Park Hospital, Frimley

BN2 1EX UK

Brighton and Sussex University Hospitals NHS Trust, Brighton

RG24 9NA, UK

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke

CF31 1RQ

Princess of Wales Hospital, Mid Glamorgan

EH4 2XU

Western General Hospital, Edinburgh

SE5 9RS

Kings's College Hospital, London

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY