Renal Calculi
Conditions
Brief summary
This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.
Detailed description
This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.
Interventions
DEVICEMOSES laser system
A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults between the ages of 18-80. * Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure. * Must be suitable for a flexible ureteroscopy as determined by the MD * Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm * An average stone density of at least 1000 Hounsfield units.
Exclusion criteria
* Those with a stone burden less than 10mm or more than 20mm. * Those with an average stone density below 1000 Hounsfield units. * Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery * Patients that cannot undergo ureteral access sheath placement * Patients with abnormal anatomy such as horseshoe kidney * Patients with a history of: * Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi * Ipsilateral ureteral strictures * Prior radiotherapy of the abdomen or pelvis * Neurogenic bladder * Spinal cord injuries * Those who are pregnant * Currently being treated for infection or cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced OR time | 2 hours | Hybrid technique will result in overall reduced OR time |
| Less Energy Transmission to Patient | 2 hours | Hybrid technique will have less energy transmission to the patient |
Secondary
| Measure | Time frame |
|---|---|
| Stone Free | 1 month after surgery |
Countries
United States
Outcome results
None listed