Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

Indiana Kidney Stone Institute

Status: Completed

Conditions: Benign Prostatic Hypertrophy Requiring Surgical Intervention

Treatments: Device: Lumenis VersaCut Morcellator; Device: Wolf Piranha Morcellator

Study type: Interventional

Funder types: Other

Identifiers

NCT02195622

1305011478R001

Details and patient eligibility

About

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).

Full 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

Enrollment: 74 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
• Able to give informed consent.
• Age 18 years or older

Exclusion criteria

• • Inability to give informed consent.

  • Age less than 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Lumenis VersaCut Morcellator

Other group

Description:

Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation

Treatment:

Device: Lumenis VersaCut Morcellator

Wolf Piranha Morcellator

Other group

Description:

Wolf Piranha Morcellator will be utilized for prostate tissue morcellation

Treatment:

Device: Wolf Piranha Morcellator