Robotic assisted surgery for benign prostatic hyperplasia (BPH)
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
The Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures
Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
RECRUITINGHospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, Chile
RECRUITINGTauranga Urology Research Limited
Tauranga, New Zealand
RECRUITINGNumber of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
This endpoint measures the number of participants who successfully complete both the enucleation and morcellation phases of robot-assisted HoLEP (Holmium Laser Enucleation of the Prostate) without the need to convert to a conventional HoLEP or an alternative surgical procedure for treating BPH-related LUTS.Successful completion is defined as completing both phases without using additional devices . This excludes the Roll-in subjects and the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure.
Time frame: During the procedure.
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
Proportion of subjects with adverse events rated as probably or definitely related to the study procedure (robot-assisted HoLEP or RoLEP) classified as Clavien-Dindo Grade 3a or higher through 30 days post-treatment.
Time frame: From procedure date to 30 days
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of capsular perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure
Time frame: From procedure date to 30 days.
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of bladder perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure.
Time frame: From procedure date to 30 days.
Number of Participants with Ureteric Orifice Damage Requiring Intervention
This outcome assesses the incidence of ureteric orifice damage leading to stricture, stenting, or any other sequelae or subsequent intervention.
Michael Nketiah
CONTACT
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Time frame: From procedure date to 30 days.
Length of Hospital Stay Post-Procedure
This outcome measures the total length of hospital stay required following the HoLEP procedure.
Time frame: From procedure date to 30 days
Length of Catheterization Post-Procedure
This outcome measures the total duration of catheterization following the procedure.
Time frame: From procedure date to 30 days
Operative Time for Procedure Completion
This outcome measures the total time required to complete the HoLEP procedure.
Time frame: During the procedure.
Number of Participants with Repeat Hospitalization for Genitourinary Conditions
This outcome measures the incidence of repeat hospitalizations due to genitourinary conditions within 30 days post-procedure.
Time frame: From procedure date to 30 days post-procedure.