Trial Outcomes & Findings for Trial Assessing Renal Damage During Ureteroscopy (NCT NCT05350423)
NCT ID: NCT05350423
Last Updated: 2023-12-07
Results Overview
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
Baseline, 1 hour postoperatively, and 10 days postoperatively
Results posted on
2023-12-07
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
|
54
|
54
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
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
|
3
|
3
|
|
Overall Study
screen failure
|
5
|
6
|
Baseline Characteristics
Trial Assessing Renal Damage During Ureteroscopy
Baseline characteristics by cohort
| Measure |
Thulium Fibre Laser (TFL)
n=46 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=45 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=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 hour postoperatively, and 10 days postoperativelyUrinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=46 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=45 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.
|
|---|---|---|
|
Change in Kidney Injury Molecule-1 (KIM-1)
Baseline
|
0.01077 ng/ml
Standard Deviation 0.0087
|
0.01228 ng/ml
Standard Deviation 0.0124
|
|
Change in Kidney Injury Molecule-1 (KIM-1)
1 hour post-op
|
0.0246 ng/ml
Standard Deviation 0.0243
|
0.02413 ng/ml
Standard Deviation 0.0229
|
|
Change in Kidney Injury Molecule-1 (KIM-1)
10 days post-op
|
0.0161 ng/ml
Standard Deviation 0.0127
|
0.0188 ng/ml
Standard Deviation 0.0118
|
PRIMARY outcome
Timeframe: Baseline, 1 hour postoperatively, and 10 days postoperativelyUrinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=46 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=45 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.
|
|---|---|---|
|
Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)
baseline
|
0.5263 ng/ml
Standard Deviation 0.9338
|
0.5723 ng/ml
Standard Deviation 1.4454
|
|
Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)
1 hour post-op
|
2.5181 ng/ml
Standard Deviation 4.4884
|
2.4486 ng/ml
Standard Deviation 4.6525
|
|
Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)
10 days post-op
|
1.8233 ng/ml
Standard Deviation 2.4811
|
2.4499 ng/ml
Standard Deviation 6.8280
|
PRIMARY outcome
Timeframe: Baseline, 1 hour postoperatively, and 10 days postoperativelyUrinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=46 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=45 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.
|
|---|---|---|
|
Change in β2-microglobulin (β2M)
baseline
|
2.1262 ng/ml
Standard Deviation 3.5700
|
2.7747 ng/ml
Standard Deviation 6.5284
|
|
Change in β2-microglobulin (β2M)
1 hour post-op
|
25.6231 ng/ml
Standard Deviation 96.8722
|
17.1472 ng/ml
Standard Deviation 42.5166
|
|
Change in β2-microglobulin (β2M)
10 days post-op
|
12.5832 ng/ml
Standard Deviation 54.7001
|
4.4599 ng/ml
Standard Deviation 14.0700
|
SECONDARY outcome
Timeframe: Day 1, IntraoperativelyOperative time (minutes) is calculated from time of procedure start (insertion of endoscope into urethral meatus) to time of removal of endoscope from urethral meatus after procedure completion.
Outcome measures
| Measure |
Thulium Fibre Laser (TFL)
n=46 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=45 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.
|
|---|---|---|
|
Operative Time
|
52.5 minutes
Interval 42.8 to 72.3
|
56.0 minutes
Interval 42.0 to 68.0
|
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