NCT02195622

Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Indiana Kidney Stone Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).

Detailed description

Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity. A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure. Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device

Conditions

• Benign Prostatic Hypertrophy Requiring Surgical Intervention

Interventions

Type	Name	Description
DEVICE	Lumenis VersaCut Morcellator
DEVICE	Wolf Piranha Morcellator

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2016-02-01
• First posted: 2014-07-21
• Last updated: 2019-03-11
• Results posted: 2019-03-11

Locations

1 site across 1 country: United States