Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers
Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study
1 other identifier
interventional
105
1 country
1
Brief Summary
The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:
- decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
- increasing the flexible ureteroscope tip deflection lower pole stones availability;
- decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
- increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter
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 Mar 2020
Typical duration 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
March 12, 2020
CompletedStudy Start
First participant enrolled
March 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJuly 22, 2021
July 1, 2021
2.2 years
March 12, 2020
July 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laser-on time
Time of laser emission during surgery, seconds
during surgery
Secondary Outcomes (8)
adverse events
during surgery and 6 months after surgery
Operative time
during surgery
Hemoglobin drop
1 day after surgery
Catheter stay
1 week
hospitalization length
1 week
- +3 more secondary outcomes
Study Arms (3)
SP TFL RIRS with 145 mcm fiber
EXPERIMENTALSuperpulse thulium fiber laser RIRS with 145 mcm laser fiber
SP TFL RIRS with 200 mcm fiber
EXPERIMENTALSuperpulse thulium fiber laser RIRS with 200 mcm laser fiber
Ho:YAG RIRS with 200 mcm fiber
ACTIVE COMPARATORHo:YAG laser RIRS with 200 mcm laser fiber
Interventions
Eligibility Criteria
You may qualify if:
- Males and Females \> 18 y.o.;
- Radiologically confirmed (CT) kidney stone;
- Stone size from 10 to 20 mm.
You may not qualify if:
- Multiple (more than 3) kidney stones \> 5 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director for research
Study Record Dates
First Submitted
March 12, 2020
First Posted
April 15, 2020
Study Start
March 13, 2020
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
July 22, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share