Trial Outcomes & Findings for Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings (NCT NCT02683993)
NCT ID: NCT02683993
Last Updated: 2025-11-10
Results Overview
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Stone clearance based on 1 month follow-up imaging data
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Stone Breaking
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
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 |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 11.2 • n=10 Participants
|
60.9 years
STANDARD_DEVIATION 15.4 • n=10 Participants
|
61.6 years
STANDARD_DEVIATION 13.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Stone clearance based on 1 month follow-up imaging datastone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Stone Clearance
Complete clearance
|
6 Participants
|
6 Participants
|
|
Stone Clearance
Evidence of fragments not requiring intervention
|
3 Participants
|
4 Participants
|
|
Stone Clearance
Evidence of fragments requiring an additional intervention
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedurePost-procedure catheterization by group
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Post-procedure Catheterization
Ureteric catheter not placed at the end of procedure
|
9 Participants
|
9 Participants
|
|
Post-procedure Catheterization
Ureteric catheter placed at the end of procedure and not removed at hospital discharge
|
1 Participants
|
0 Participants
|
|
Post-procedure Catheterization
Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: during the procedureDuration (in minutes) of the procedure as an indicator for treatment efficiency.
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Procedure Time
|
46.3 Minutes
Standard Deviation 24.8
|
36.1 Minutes
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: as measured during the procedureThe need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Usage of Alternative Stone Extracting Devices
Any alternate stone extracting devices used
|
0 Participants
|
1 Participants
|
|
Usage of Alternative Stone Extracting Devices
No alternate stone extracting devices used
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Procedure through hospital dischargeHospital duration was measured to evaluate treatment efficiency
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Hospital Stay
Same day hospital discharge
|
10 Participants
|
8 Participants
|
|
Hospital Stay
Next day hospital discharge
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: IntraoperativeNumber of participants with complications that occur during the procedure.
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Number of Participants With Intraoperative Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralVisibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Visibility During Procedure
Poor
|
0 Participants
|
0 Participants
|
|
Visibility During Procedure
Fair
|
0 Participants
|
0 Participants
|
|
Visibility During Procedure
Good
|
0 Participants
|
1 Participants
|
|
Visibility During Procedure
Very Good
|
7 Participants
|
6 Participants
|
|
Visibility During Procedure
Excellent
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: IntraoperativeOccurrence of retropulsion by group
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Number of Participants With Occurrence of Retropulsion
Did not occur
|
8 Participants
|
10 Participants
|
|
Number of Participants With Occurrence of Retropulsion
Occurred several times but could be controlled
|
2 Participants
|
0 Participants
|
|
Number of Participants With Occurrence of Retropulsion
Occurred several times and was difficult to control
|
0 Participants
|
0 Participants
|
|
Number of Participants With Occurrence of Retropulsion
Stone lost to retropulsion
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IntraoperativePerformance rating of ability to reach stone fragments by group
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Ability to Reach Stone Fragments
Easily performed
|
6 Participants
|
9 Participants
|
|
Ability to Reach Stone Fragments
Performed well
|
4 Participants
|
1 Participants
|
|
Ability to Reach Stone Fragments
Performed with difficulty
|
0 Participants
|
0 Participants
|
|
Ability to Reach Stone Fragments
Impossible to perform
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IntraoperativeDamage to scope or fiber by group
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Damage to Scope or Fiber
Scope damage · Yes
|
0 Participants
|
0 Participants
|
|
Damage to Scope or Fiber
Scope damage · No
|
10 Participants
|
10 Participants
|
|
Damage to Scope or Fiber
Fiber damage · Yes
|
0 Participants
|
0 Participants
|
|
Damage to Scope or Fiber
Fiber damage · No
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: IntraoperativeFiber transmission (preserving energy transmission during lasing) by group
Outcome measures
| Measure |
Stone Breaking
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 Participants
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Fiber Transmission
Easily performed
|
8 Participants
|
9 Participants
|
|
Fiber Transmission
Performed well
|
2 Participants
|
1 Participants
|
|
Fiber Transmission
Performed with difficulty
|
0 Participants
|
0 Participants
|
|
Fiber Transmission
Impossible to perform
|
0 Participants
|
0 Participants
|
Adverse Events
Stone Breaking
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stone Dusting
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stone Breaking
n=10 participants at risk
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
Stone Dusting
n=10 participants at risk
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
|
|---|---|---|
|
Renal and urinary disorders
Bleeding
|
0.00%
0/10 • Intra-operative to 1 month post-procedure
Adverse event information was collected via assessments at follow-up visits.
|
10.0%
1/10 • Number of events 1 • Intra-operative to 1 month post-procedure
Adverse event information was collected via assessments at follow-up visits.
|
|
General disorders
Other
|
0.00%
0/10 • Intra-operative to 1 month post-procedure
Adverse event information was collected via assessments at follow-up visits.
|
10.0%
1/10 • Number of events 1 • Intra-operative to 1 month post-procedure
Adverse event information was collected via assessments at follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place