Trial Outcomes & Findings for Thulium vs. Hol:YAG Laser (NCT NCT05808257)
NCT ID: NCT05808257
Last Updated: 2025-01-29
Results Overview
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
6-12 weeks postoperative
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
Thulium Fibre Laser (TFL)
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Thulium Fibre Laser (TFL)
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
Baseline Characteristics
Thulium vs. Hol:YAG Laser
Baseline characteristics by cohort
| Measure |
Thulium Fibre Laser (TFL)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
n=5 Participants
|
60.0 years
n=7 Participants
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.2 kg/m^2
n=5 Participants
|
26.6 kg/m^2
n=7 Participants
|
26.8 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-12 weeks postoperativeStone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Number of Participants With Stone Free Status
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Intraoperatively (Day 1)Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Fragmentation Speed
|
0.25 mm3/sec
Interval 0.17 to 0.46
|
0.29 mm3/sec
Interval 0.18 to 0.39
|
SECONDARY outcome
Timeframe: Intraoperatively (Day 1)Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Lasing Activity
|
58.0 percent of time using laser
Interval 39.6 to 67.3
|
46.1 percent of time using laser
Interval 36.3 to 55.5
|
SECONDARY outcome
Timeframe: Intraoperatively (Day 1)Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Thulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
|
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
n=33 Participants
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Holmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
|
|---|---|---|
|
Energy Utilization
|
13.6 J/mm3
Interval 6.4 to 22.3
|
17.7 J/mm3
Interval 10.2 to 38.7
|
Adverse Events
Thulium Fibre Laser (TFL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mantu Gupta
Icahn School of Medicine at Mount Sinai
Phone: 212-241-1272
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place