N/A
N=20
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Stone Clearance
Bottom Line
View on ClinicalTrials.gov: NCT02683993 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Stone Clearance — 6; 6; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Clearance |
6; 6; 3; 4; 1; 0 | — |
| PRIMARY Post-procedure Catheterization |
9; 9; 1; 0; 0; 1 | — |
| PRIMARY Procedure Time |
46.3; 36.1 | — |
| PRIMARY Usage of Alternative Stone Extracting Devices |
0; 1; 10; 9 | — |
| PRIMARY Hospital Stay |
10; 8; 0; 2 | — |
| SECONDARY Number of Participants With Intraoperative Complications |
0; 0 | — |
| SECONDARY Visibility During Procedure |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Occurrence of Retropulsion |
8; 10; 2; 0; 0; 0 | — |
| SECONDARY Ability to Reach Stone Fragments |
6; 9; 4; 1; 0; 0 | — |
| SECONDARY Damage to Scope or Fiber |
0; 0; 10; 10; 0; 0 | — |
| SECONDARY Fiber Transmission |
8; 9; 2; 1; 0; 0 | — |
Summary
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
Eligibility Criteria
Inclusion Criteria
- Subject will be older than 18 years of age
- Subject was diagnosed with renal calculi meeting the following criteria:
- Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
- Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
- Subject is a candidate for FURS procedure
- Subject is willing and has signed the Informed Consent Form
Exclusion Criteria
- Subject has undergone a previous treatment for stones in the same kidney
- Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
- Female subject is pregnant
- Concomitant anticoagulant medication that cannot be suspended during surgery
Data sourced from ClinicalTrials.gov (NCT02683993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.