Benign Prostatic Hyperplasia, Enlarged Prostate (BPH)
Conditions
Keywords
HoLEP, Holmium laser
Brief summary
The objective of this study is to compare the Magneto 150 holmium laser to the current MOSES 2.0 technology to see if there is a benefit in decreased hemostasis time intraoperatively.
Detailed description
The Magneto 150 is a high-powered 150W holmium laser that offers similar pulse-modulation benefits of MOSES 2.0, which facilitates effective dissection and enucleation of the tissue plane while also offering a new first-of-its kind proprietary Magneto setting which allows for very low peak power of 500W and longer pulse duration which allows for better hemostasis.
Interventions
DEVICEMagneto 150 holmium laser
The HoLEP procedure will be performed using the Quanta Magneto 150 holmium laser
DEVICEMoses 2.0 holmium laser
The HoLEP procedure will be performed using the Moses 2.0 holmium laser
Sponsors
Northwestern University
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will be randomized to undergo HoLEP with their surgeon using the MOSES 2.0 holmium laser or the Magneto 150 holmium laser. Participants will not know their randomization prior to procedure, but they will be able to find out at any time after the HoLEP procedure.
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms * Internet access and a device to complete postoperative questionnaires (smartphone, tablet, laptop or desktop computer)
Exclusion criteria
* Patients who lack decisional capacity * Patients unable to read/speak English * Patients who are on a blood thinner (anticoagulation medication) * Patients who do not have internet access to complete postoperative surveys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean hemostasis time | During surgery | Overall intraoperative hemostasis time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean (average) enucleation time | During surgery | Time taken to surgically remove excess prostate tissue while leaving the shell of the prostate intact and within the body. |
| Total operative time | During surgery | Time taken from official procedure start to completion (not accounting for the time that the patient is wheeled in, prepped and out of the operating room). |
| Hemostasis efficiency | During surgery | minutes/gram (prostate tissue removed) |
Countries
United States
Contacts
CONTACTAlyssa McDonald, MPH
PRINCIPAL_INVESTIGATORPerry Xu, MD
Northwestern University
Outcome results
None listed