Status:
RECRUITING
EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
Lead Sponsor:
Fundacio Puigvert
Conditions:
Prostatic Hyperplasia
Surgery
Eligibility:
MALE
40-90 years
Phase:
NA
Brief Summary
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various avai...
Detailed Description
Surgery and Follow-up Schedule * Surgeries will be performed between September 2024 and September 2025. * Initial follow-up at 3 months. * Completion of the first phase of the study: March 2026. Sch...
Eligibility Criteria
Inclusion
- Males aged between 40 and 90 years.
- Patients who, due to their lower urinary tract symptoms, are candidates for
- BPH surgery, including:
- Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
- Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
- Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
- Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%.
Exclusion
- Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
- History of prostate surgery or pelvic radiotherapy.
- Diagnosis or suspicion of prostate cancer or urothelial cancer.
- Body mass index superior to 30.
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06565741
Start Date
September 3 2024
End Date
September 1 2028
Last Update
June 22 2025
Active Locations (3)
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1
Fundacio Puigvert
Barcelona, BARCELONA, Spain, 08025
2
Clinic Hospital of Barcelona
Barcelona, BARCELONA, Spain, 08036
3
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain, 08907