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Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

NCT ID: NCT02195622

Last Updated: 2019-03-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

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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).

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Detailed Description

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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

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Benign Prostatic Hypertrophy Requiring Surgical Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumenis VersaCut Morcellator

Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation

Group Type OTHER

Lumenis VersaCut Morcellator

Intervention Type DEVICE

Wolf Piranha Morcellator

Wolf Piranha Morcellator will be utilized for prostate tissue morcellation

Group Type OTHER

Wolf Piranha Morcellator

Intervention Type DEVICE

Interventions

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Lumenis VersaCut Morcellator

Intervention Type DEVICE

Wolf Piranha Morcellator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Richard Wolf Medical Instruments Corporation (RWMIC)

UNKNOWN

Sponsor Role collaborator

Indiana Kidney Stone Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IU Health Physicians Urology

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1305011478R001

Identifier Type: -

Identifier Source: org_study_id

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