Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

NACompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

September 20, 2021

Study Completion Date

October 6, 2022

Conditions
Prostate HyperplasiaBenign Prostatic HyperplasiaBenign Prostatic HypertrophyBenign Prostatic Hypertrophy With Outflow Obstruction
Interventions
PROCEDURE

Trans-Perineal Laser Ablation of Prostate

"TPLA treatment will be performed using the EchoLaser EVO system (Elesta SpA - Calenzano, FI, Italy). EchoLaser EVO consists of four echolasers, a multi-source laser system with a wavelength of 1064nm and Echolaser Smart Interface (ESI), a treatment planning device for safely inserting introductor needles and optical fibers into prostate tissue. EchoLaser therapy is a micro-invasive percutaneous procedure that uses laser light transmitted through applicators (optical fibers) for a few minutes, causing a heating of the affected tissue to its irreversible damage in situ, without the need to remove it. EchoLaser therapy, through flat-tip fibers, produces an ellipsoidal clotting area (area where the tissue has irreversible damage). EchoLaser therapy will be performed under ultrasound guidance."

PROCEDURE

Trans-Urethral Resection of Prostate

TURP is the gold standard for the treatment of benign prostatic obstruction. It will be performed by using a bipolar energy resectoscope. The procedure will be carried out with patient in a lithotomic position.

Trial Locations (1)

00175

San Carlo di Nancy Hospital, Roma

All Listed Sponsors
collaborator

Elesta S.R.L.

INDUSTRY

lead

San Carlo di Nancy Hospital

OTHER

NCT04781049 - Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial | Biotech Hunter | Biotech Hunter