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Laser Therapy

Thulium Laser 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the duration of the procedure

Awards & highlights

HOTLaser Trial 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.Check my eligibility

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.See study design

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.

HOTLaser Trial 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.

HOTLaser Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the duration of the operation

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Laser Treatment Time

Secondary outcome measures

Retreatment rate

Stone-Free Rate

Total Operative Time

Other outcome measures

Length of stay

Safety Profile and Adverse Events

Subjective pain scores

HOTLaser 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MaineHealthLead Sponsor

72 Previous Clinical Trials

49,475 Total Patients Enrolled

Boston Scientific CorporationIndustry Sponsor

720 Previous Clinical Trials

932,970 Total Patients Enrolled

3 Trials studying Kidney Stones

60 Patients Enrolled for Kidney Stones

David W Sobel, MDPrincipal InvestigatorMaineHealth

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment for this medical study limited to individuals who have reached 18 years of age or older?

"Recruitment for this study targets individuals over 21 years of age but under the age of 90."

Answered by AI

Are there any available slots for patients to participate in this research study?

"According to details on clinicaltrials.gov, recruitment for this research project is currently closed. The trial was initially listed on 3/1/2024 and last modified on 2/11/2024. While this specific study is not enrolling participants at the moment, it's worth noting that there are currently 82 other active trials looking for eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Holmium Laser and Thulium Laser for Mini PCNL

David Sobel 2024. "Comparison of Holmium Laser and Thulium Laser for Mini PCNL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06266793.

All > Kidney Stone