NCT02195622

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

July 17, 2014

Results QC Date

June 20, 2018

Last Update Submit

March 8, 2019

Conditions

Benign Prostatic Hypertrophy Requiring Surgical Intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lumenis VersaCut Morcellator

OTHER

Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation

Device: Lumenis VersaCut Morcellator

Wolf Piranha Morcellator

OTHER

Wolf Piranha Morcellator will be utilized for prostate tissue morcellation

Device: Wolf Piranha Morcellator

Interventions

Lumenis VersaCut MorcellatorDEVICE
Lumenis VersaCut Morcellator
Wolf Piranha MorcellatorDEVICE
Wolf Piranha Morcellator

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to give informed consent.
  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

Title
James Lingeman, MD
Organization
IU Health Physicians Urology
317-962-3700

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

February 1, 2016

Last Updated

March 11, 2019

Results First Posted

March 11, 2019

Record last verified: 2019-03

Locations

US(1)