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Laser Therapy

Holmium vs Thulium Lasers for Kidney Stones (HOTLaser Trial)

N/A
Waitlist Available
Led By David W Sobel, MD
Research Sponsored by MaineHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stone burden (multiple stones acceptable) with largest stone 1cm - 3 cm in greatest dimension on bone window of noncontrast CT within a 6 month preoperative period
Age 21 or older
Must not have
Are currently prescribed buprenorphine or methadone, or carry active diagnosis of chronic opioid use disorder
Patients scheduled to undergo concurrent non-PCNL procedure such as contralateral ureteroscopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration of the procedure
Awards & highlights
No Placebo-Only Group

Summary

"This trial is comparing two types of lasers, one from Boston Scientific and one from Olympus, to see which one is better for treating medium-to-large kidney stones using a minimally invasive procedure."

Who is the study for?
This trial is for individuals with medium-to-large kidney stones who are candidates for a minimally invasive surgical procedure called mini PCNL. Specific eligibility details aren't provided, but typically participants should be in stable health and meet certain criteria set by the surgeon.
What is being tested?
The study compares two types of lasers used in kidney stone surgery: the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser and the Olympus Soltive Superpulsed thulium fiber laser (TFL). Patients will be randomly assigned to one of these treatments.
What are the potential side effects?
While specific side effects are not listed, typical risks associated with laser kidney stone treatment include bleeding, infection, pain during or after surgery, potential damage to surrounding tissues, and possible need for additional procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have kidney stones, with the largest being between 1cm and 3cm.
Select...
I am 21 years old or older.
Select...
I am scheduled for a mini surgery to remove kidney stones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently on buprenorphine or methadone, or have a chronic opioid use disorder.
Select...
I am scheduled for a kidney stone removal procedure along with another urinary tract procedure.
Select...
I am under 21 years old.
Select...
I have a urinary tract infection that hasn't been treated.
Select...
I do not have any uncontrolled bleeding disorders.
Select...
I have an abnormality in my upper urinary tract, like a narrowing or blockage.
Select...
I have a surgically altered route for urine to leave my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of the operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of the operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Laser Treatment Time
Secondary study objectives
Retreatment rate
Stone-Free Rate
Total Operative Time
Other study objectives
Length of stay
Safety Profile and Adverse Events
Subjective pain scores

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: Thulium LaserActive Control1 Intervention
Participants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser
Group II: Holmium LaserActive Control1 Intervention
Participants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser

Find a Location

Who is running the clinical trial?

MaineHealthLead Sponsor
74 Previous Clinical Trials
43,853 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
744 Previous Clinical Trials
857,771 Total Patients Enrolled
David W Sobel, MDPrincipal InvestigatorMaineHealth
~35 spots leftby Jun 2027
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