N/A
N=270
Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
Kidney Stones
Bottom Line
View on ClinicalTrials.gov: NCT00952315 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Stone Clearance Time in mm2/Min — 24.0; 28.9; 32.3 mm^2/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cyberwand (Device); Stonebreaker (Device); Lithoclast Select (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana Kidney Stone Institute
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Clearance Time in mm2/Min |
24.0; 28.9; 32.3 | — |
| SECONDARY Stone-free After First Procedure |
33; 43; 39 | — |
| SECONDARY Secondary Procedure Required |
15; 16; 24 | — |
| SECONDARY Ureteral Stent Placed |
3; 4; 5 | — |
| SECONDARY Nephrostomy Tube Placed |
55; 59; 63 | — |
| SECONDARY Use of Other Device |
8; 9; 5 | — |
| SECONDARY EBL>400mL |
4; 2; 3 | — |
| SECONDARY RBC Transfusion |
3; 2; 2 | — |
| SECONDARY Length of Stay |
1.9; 2.5; 2.6 | — |
| SECONDARY Post-operative Complications |
10; 10; 11 | — |
Summary
The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
- Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
- Age 18 years or older
- Able to give informed consent
Exclusion Criteria
- Size of single largest stone less than 2 cm
- Pregnancy
- Active urinary tract infection
- Extracorporeal shockwave lithotripsy within the last three months
- Complex stone anticipating multiple access sites
- Stones that are not clearly able to be measured on KUB or CT scan
- Inability to give informed consent
- Age less than 18 years
Data sourced from ClinicalTrials.gov (NCT00952315). 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.