Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565741
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
EEAP Using Moses 20 Technology Vs the Thulium Fiber Laser in Medium-Large Prostates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 20 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Scheduled of Visits Selection Visit 1-Month Postoperative Visit 3-Month Follow-up 6-Month Follow-up Annual Follow-up Visit 1-3 years
Sample size calculation was done using the main outcome variable total surgical time Previous studies indicate that surgical time for ThuFLEP is 716 minutes 8 The time for MoLEP may be at least 5 minutes less Accepting an alpha risk of 5 and a beta risk of 20 in a two-tailed test a total of 120 patients are needed 60 in each study group A common standard deviation of 9 minutes change is assumed A loss to follow-up rate of 15 has been estimated
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects The calculation will be carried out with the RndSeq macro for SPSS Statistics It will be conducted centrally by a person independent of the surgeon
Statistical Analysis For quantitative variables measures of central tendency and dispersion will be provided Normality tests will be conducted using the Shapiro-Wilk test For qualitative variables valid percentages will be shown Sociodemographic and clinical data as well as the main study variables will be compared between study groups using the Students t-test Mann-Whitney U test in case of non-normality Chi-square test or Fishers test if any observed frequency is 5 will be used for qualitative variables A multivariate linear regression model will be constructed to determine variables related to surgical time Beta coefficients and 95 confidence intervals CI will be determined A preliminary study will be conducted on potential confounding and interacting factors Adjustment will be made for clinically or bibliographically relevant variables Interaction will be tested using the likelihood ratio test A significant difference will be accepted in all tests with a p-value 005 R Studio statistical package V251 will be used for data analysis
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
Scheduled of Visits Selection Visit 1-Month Postoperative Visit 3-Month Follow-up 6-Month Follow-up Annual Follow-up Visit 1-3 years
Sample size calculation was done using the main outcome variable total surgical time Previous studies indicate that surgical time for ThuFLEP is 716 minutes 8 The time for MoLEP may be at least 5 minutes less Accepting an alpha risk of 5 and a beta risk of 20 in a two-tailed test a total of 120 patients are needed 60 in each study group A common standard deviation of 9 minutes change is assumed A loss to follow-up rate of 15 has been estimated
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects The calculation will be carried out with the RndSeq macro for SPSS Statistics It will be conducted centrally by a person independent of the surgeon
Statistical Analysis For quantitative variables measures of central tendency and dispersion will be provided Normality tests will be conducted using the Shapiro-Wilk test For qualitative variables valid percentages will be shown Sociodemographic and clinical data as well as the main study variables will be compared between study groups using the Students t-test Mann-Whitney U test in case of non-normality Chi-square test or Fishers test if any observed frequency is 5 will be used for qualitative variables A multivariate linear regression model will be constructed to determine variables related to surgical time Beta coefficients and 95 confidence intervals CI will be determined A preliminary study will be conducted on potential confounding and interacting factors Adjustment will be made for clinically or bibliographically relevant variables Interaction will be tested using the likelihood ratio test A significant difference will be accepted in all tests with a p-value 005 R Studio statistical package V251 will be used for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None