Clinical Outcomes and Healthcare Economics of SOLTIVE Compared to Ho:YAG Laser in Urolithiasis
1 other identifier
interventional
100
1 country
1
Brief Summary
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium laser compared to Ho:YAG laser for the treatment of urolithiasis. The hypothesis is that utilizing the SOLTIVE Thulium laser for the treatment of urolithiasis will result in a more efficient procedure, with comparable stone free rate to that of Holmium laser and subjective improvement in physician satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedMay 7, 2026
May 1, 2026
2.6 years
July 16, 2021
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the stone free rate of patients undergoing ureteroscopy with laser lithotripsy for urolithiasis at first follow up visit
To evaluate the stone free rate of patients undergoing ureteroscopy with laser lithotripsy for urolithiasis with the SOLTIVE Thulium Fiber Laser in comparison to Ho:YAG laser with repeat imaging at the first follow up clinic visit.
6 months
Secondary Outcomes (11)
To compare Operation time SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.
1 day
To compare laser time SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.
1 day
To compare pedal time SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.
1 day
To compare laser setting SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.
1 day
To compare use of basket during SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.
1 day
- +6 more secondary outcomes
Study Arms (2)
SOLTIVE Thulium Fiber Laser
ACTIVE COMPARATORSOLTIVE Thulium Fiber Laser group (laser A)
Ho:YAG Laser
ACTIVE COMPARATORHo:YAG Laser group (laser B)
Interventions
Patients randomized to Arm B will undergo surgery to remove their kidney stone with FDA approved Ho:YAG laser.
Patients randomized to Arm A will undergo surgery to remove their kidney stone with FDA approved SOLTIVE Thulium Fiber Laser.
Eligibility Criteria
You may qualify if:
- Patients must be 18 years of age or older
- Patients must be diagnosed with single stone burden \<2.0 cm
- Patients must opt for definitive treatment with ureteroscopy with lase lithotripsy and stone basket extraction
You may not qualify if:
- Patients with multiple stones or stones bilaterally
- Patient with stones \>2.0cm
- Patient who wish to continue with trial of passage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson Molina, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2021
First Posted
August 10, 2021
Study Start
September 1, 2022
Primary Completion
March 26, 2025
Study Completion
March 25, 2026
Last Updated
May 7, 2026
Record last verified: 2026-05