Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

Benign Prostatic Hypertrophy Requiring Surgical Intervention Clinical Trial

Official title:

Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195622
• Other study ID #: 1305011478R001
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2019
• Source: Indiana Kidney Stone Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy Requiring Surgical Intervention
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Device:
• Lumenis VersaCut Morcellator

• Wolf Piranha Morcellator

Locations

Country	Name	City	State
United States	IU Health Physicians Urology	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute	Richard Wolf Medical Instruments Corporation (RWMIC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morcellation Rate	Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."	Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth