Trial Outcomes & Findings for Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones (NCT NCT03526458)
NCT ID: NCT03526458
Last Updated: 2021-09-20
Results Overview
The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
up to 6 hours
Results posted on
2021-09-20
Participant Flow
Participant milestones
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Overall Study
Surgeries rescheduled or cancelled due to COVID
|
2
|
2
|
|
Overall Study
Stone passed, surgery cancelled
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lack of equipment
|
1
|
1
|
Baseline Characteristics
Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
Baseline characteristics by cohort
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 hoursThe time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
Outcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Fragmentation Time
|
24.5 Minutes
Standard Deviation 19.2
|
7.9 Minutes
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: up to 6 hoursOutcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Total Operative Time
|
75.7 Minutes
Standard Deviation 20.6
|
64.3 Minutes
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Retrospective review of health chart at BaselinePre-operative stone size (on pre-operative CT) will be reported in millimeters.
Outcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Pre-Operative Stone Size
|
11.2 mm
Standard Deviation 5.2
|
9.2 mm
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: up to 6 hoursUrinary stone location will be classified as renal or ureter.
Outcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Number of Participants With Either Ureteral or Renal Location of Urinary Stone
Ureteral
|
8 Participants
|
7 Participants
|
|
Number of Participants With Either Ureteral or Renal Location of Urinary Stone
Renal
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 6 hoursOutcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Number of Participants Treated for Either Single or Multiple Urinary Stones
Single
|
8 Participants
|
14 Participants
|
|
Number of Participants Treated for Either Single or Multiple Urinary Stones
Multiple
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 6 hoursOutcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Density of Urinary Stones
|
935.2 Hounsfield units
Standard Deviation 367.9
|
924.7 Hounsfield units
Standard Deviation 374.5
|
SECONDARY outcome
Timeframe: up to 6 hoursSize of fragments created will be assessed using the laser fiber size as a comparison.
Outcome measures
| Measure |
Holmium:YAG Laser: 0.2J&15Hz
n=12 Participants
Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Holmium:YAG Laser: 0.8J&15Hz
n=15 Participants
Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.
Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|---|---|---|
|
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
1mm
|
1 Participants
|
5 Participants
|
|
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
2mm
|
10 Participants
|
10 Participants
|
|
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
3mm
|
1 Participants
|
0 Participants
|
Adverse Events
Holmium:YAG Laser: 0.2J&15Hz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Holmium:YAG Laser: 0.8J&15Hz
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
Shuang Li
University of Wisconsin, School of Medicine and Public Health, Department of Urology
Phone: 6082638336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place