NCT06565741 - EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

September 3, 2024

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions

Prostatic HyperplasiaSurgeryEndoscopic Anatomical Enucleation of the Prostate (EEAP)

Interventions

PROCEDURE

MoLEP

Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

PROCEDURE

ThuFLEP

Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Trial Locations (3)

08025

RECRUITING

Fundacio Puigvert, Barcelona

08036

RECRUITING

Clinic Hospital of Barcelona, Barcelona

08907

NOT_YET_RECRUITING

Hospital Univesitari de Bellvitge, L'Hospitalet de Llobregat