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Laser Sheath
Laser Scope Size Comparison for Prostate Enlargement
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males aged 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms
Be older than 18 years old
Must not have
Patients who lack decisional capacity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two different sizes of laser scopes to see which is better at removing obstructing prostate tissue during HoLEP.
Who is the study for?
This trial is for men aged 18-89 who are undergoing HoLEP to treat bothersome symptoms from an enlarged prostate. Participants must be able to make their own decisions about healthcare.
What is being tested?
The study compares two laser scopes used in HoLEP surgery: the Richard Wolf 24F and the Karl Storz 28F, to see which might be better for removing obstructing prostate tissue through the urethra.
What are the potential side effects?
Potential side effects may include discomfort or complications related to scope size during the procedure, such as bleeding, infection, or urinary issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18-89 with urinary problems planning to undergo HoLEP.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Surgery Time difference between the 24F laser scope and the 28F laser scope
Secondary study objectives
Surgeon evaluation of Laser scope bladder injury
Surgeon evaluation of Laser scope visualization
Surgeon evaluation of Laser scopes flow rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Richard Wolf 24F Laser scopeActive Control1 Intervention
Group II: Karl Storz 28F Laser scopeActive Control1 Intervention
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,647 Previous Clinical Trials
958,417 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18-89 with urinary problems planning to undergo HoLEP.I am unable to make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Richard Wolf 24F Laser scope
- Group 2: Karl Storz 28F Laser scope
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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