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Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

Primary Purpose

Benign Prostatic Hypertrophy Requiring Surgical Intervention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumenis VersaCut Morcellator
Wolf Piranha Morcellator
Sponsored by
Indiana Kidney Stone Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy Requiring Surgical Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • IU Health Physicians Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lumenis VersaCut Morcellator

Wolf Piranha Morcellator

Arm Description

Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation

Wolf Piranha Morcellator will be utilized for prostate tissue morcellation

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Full Information

First Posted
July 17, 2014
Last Updated
March 8, 2019
Sponsor
Indiana Kidney Stone Institute
Collaborators
Richard Wolf Medical Instruments Corporation (RWMIC)
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1. Study Identification

Unique Protocol Identification Number
NCT02195622
Brief Title
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Official Title
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana Kidney Stone Institute
Collaborators
Richard Wolf Medical Instruments Corporation (RWMIC)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy Requiring Surgical Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumenis VersaCut Morcellator
Arm Type
Other
Arm Description
Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation
Arm Title
Wolf Piranha Morcellator
Arm Type
Other
Arm Description
Wolf Piranha Morcellator will be utilized for prostate tissue morcellation
Intervention Type
Device
Intervention Name(s)
Lumenis VersaCut Morcellator
Intervention Type
Device
Intervention Name(s)
Wolf Piranha Morcellator
Primary Outcome Measure Information:
Title
Morcellation Rate
Description
Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."
Time Frame
Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IU Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

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