NCT06565741 EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
| NCT ID | NCT06565741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacio Puigvert |
| Condition | Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-09-03 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room. Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency. Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding. b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay. c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications. d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms. e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables. Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ivan Schwartzmann Jochamowitz, MD
PRINCIPAL INVESTIGATOR
Fundacio Puigvert
Frequently Asked Questions
Who can join the NCT06565741 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 90 Years, studying Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565741 currently recruiting?
Yes, NCT06565741 is actively recruiting participants. Contact the research team at ischwartzm@fundacio-puigvert.es for enrollment information.
Where is the NCT06565741 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain, L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT06565741 clinical trial?
NCT06565741 is sponsored by Fundacio Puigvert. The principal investigator is Ivan Schwartzmann Jochamowitz, MD at Fundacio Puigvert. The trial plans to enroll 120 participants.