A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedMarch 31, 2022
March 1, 2022
12 months
February 7, 2020
December 22, 2021
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Operative Time
time for surgery to take place
intraoperatively
Secondary Outcomes (1)
Percentage of Change of Hematocrit
Baseline to postoperatively day 1
Study Arms (2)
Holmium Laser Enucleation of Prostate
ACTIVE COMPARATORTraditional holmium laser enucleation of the prostate as currently performed
Moses Holmium Laser Enucleation of Prostate
EXPERIMENTALholmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
Interventions
Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
Eligibility Criteria
You may qualify if:
- Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams
You may not qualify if:
- Anyone actively on anticoagulation perioperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nicholas kavoussi
- Organization
- Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
January 1, 2020
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
March 31, 2022
Results First Posted
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share