Trial Outcomes & Findings for Laser Lithotripsy During URS - Holmium vs Thulium (NCT NCT04668586)
NCT ID: NCT04668586
Last Updated: 2025-03-30
Results Overview
Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
3 months after the URS
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Holmium:YAG Laser Machine
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=60 Participants
|
53 years
n=60 Participants
|
53 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=60 Participants
|
22 Participants
n=60 Participants
|
43 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=60 Participants
|
38 Participants
n=60 Participants
|
77 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Norway
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
60 participants
n=120 Participants
|
|
Stone size
Renal stones
|
12 mm
n=39 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
12 mm
n=36 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
12 mm
n=75 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
|
Stone size
Ureteral stones
|
7 mm
n=21 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
8 mm
n=24 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
8 mm
n=45 Participants • Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall)
|
|
Stone location
Renal stones - lower calyx
|
25 participants
n=25 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
22 participants
n=22 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
47 participants
n=47 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
|
Stone location
Renal stones - all other locations
|
14 participants
n=14 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
14 participants
n=14 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
28 participants
n=28 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
|
Stone location
Ureteral stones - upper
|
11 participants
n=11 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
6 participants
n=6 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
17 participants
n=17 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
|
Stone location
Ureteral stones - middle
|
1 participants
n=1 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
2 participants
n=2 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
3 participants
n=3 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
|
Stone location
Ureteral stones - lower
|
9 participants
n=9 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
16 participants
n=16 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
25 participants
n=25 Participants • The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120.
|
PRIMARY outcome
Timeframe: 3 months after the URSEvaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
Outcome measures
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=59 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Stone Free Rate
|
34 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Decided immediately after the surgerySurgical operating time
Outcome measures
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Operating Time
|
60 minutes
Interval 45.0 to 70.0
|
49 minutes
Interval 32.0 to 63.0
|
SECONDARY outcome
Timeframe: Decided immediately after the surgeryIntraoperative complications leading to abruption of the URS procedure
Outcome measures
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Intraoperative Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 months post endoscopicallyPostoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Outcome measures
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Postoperative Complications
Total participants needing readmission
|
8 Participants
|
7 Participants
|
|
Postoperative Complications
Infection
|
6 Participants
|
4 Participants
|
|
Postoperative Complications
Obstruction
|
2 Participants
|
4 Participants
|
|
Postoperative Complications
Other
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Decided immediately after the surgeryHow many needed postendoscopic stunting following the URS procedure
Outcome measures
| Measure |
Holmium:YAG Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 Participants
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Postoperative JJ-stenting
|
31 Participants
|
22 Participants
|
Adverse Events
Holmium:YAG Laser Machine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Thulium Fiber Laser Machine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Holmium:YAG Laser Machine
n=60 participants at risk
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
|
Thulium Fiber Laser Machine
n=60 participants at risk
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
|
|---|---|---|
|
Renal and urinary disorders
Postoperative complications
|
13.3%
8/60 • Number of events 60 • From surgery until 3 months folloe-up
Adverse events reported according to Clavien-Dindo classification
|
11.7%
7/60 • Number of events 60 • From surgery until 3 months folloe-up
Adverse events reported according to Clavien-Dindo classification
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place