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Procedure
Moses 2.0 Laser Treatment for Enlarged Prostate (Moses 2 Trial)
N/A
Recruiting
Led By Donald Neff
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate size 60g or less
Patients > 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using Moses 2.0 during prostate laser treatment can make the procedure more effective and safer by reducing tissue damage, improving visibility, and reducing bleeding. This trial tests
Who is the study for?
This trial is for men over 18 with bothersome urinary symptoms due to an enlarged prostate (60g or less), who choose surgery. It's not suitable for those outside this group.
What is being tested?
The study tests if Moses 2.0 technology improves the efficiency, visibility, and blood control during laser vaporization of the prostate compared to standard methods.
What are the potential side effects?
Potential side effects may include typical surgical risks such as bleeding, infection, irritation during urination, and possibly short-term urinary incontinence.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate is 60g or smaller.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The is vaporization efficiency, measured in g/min
Secondary study objectives
Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: HoLVP without the use of Moses 2.0 technologyExperimental Treatment1 Intervention
HoLVP without the use of Moses 2.0 technology
Group II: HoLVP with the use of Moses 2.0 technologyExperimental Treatment1 Intervention
HoLVP with the use of Moses 2.0 technology
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Approach
2022
N/A
~60
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
857,881 Total Patients Enrolled
4 Trials studying Lower Urinary Tract Symptoms
549 Patients Enrolled for Lower Urinary Tract Symptoms
University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,174 Total Patients Enrolled
2 Trials studying Lower Urinary Tract Symptoms
35 Patients Enrolled for Lower Urinary Tract Symptoms
Donald NeffPrincipal InvestigatorUniversity of Kansas Medical Center
2 Previous Clinical Trials
25 Total Patients Enrolled