Trial Outcomes & Findings for Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures (NCT NCT02195622)

Results Overview

Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth

Results posted on

2019-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lumenis VersaCut Morcellator Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Lumenis VersaCut Morcellator	Wolf Piranha Morcellator Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Wolf Piranha Morcellator
Overall Study STARTED	37	37
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumenis VersaCut Morcellator n=37 Participants Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Lumenis VersaCut Morcellator	Wolf Piranha Morcellator n=37 Participants Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Wolf Piranha Morcellator	Total n=74 Participants Total of all reporting groups
Age, Continuous	68 years n=37 Participants	69 years n=37 Participants	68.5 years n=74 Participants
Sex: Female, Male Female	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Sex: Female, Male Male	37 Participants n=37 Participants	37 Participants n=37 Participants	74 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	37 participants n=37 Participants	37 participants n=37 Participants	74 participants n=74 Participants

PRIMARY outcome

Timeframe: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth

Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."

Outcome measures

Outcome measures
Measure	Lumenis VersaCut Morcellator n=37 Participants Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Lumenis VersaCut Morcellator	Wolf Piranha Morcellator n=37 Participants Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Wolf Piranha Morcellator
Morcellation Rate	4.8 grams/minute Interval 1.3 to 9.5	5.6 grams/minute Interval 1.4 to 18.0

Adverse Events

Wolf Piranha Morcellator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumenis VersaCut Morcellator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Lingeman, MD

IU Health Physicians Urology

Phone: 317-962-3700

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place