Health Condition 1: N202- Calculus of kidney with calculus of ureter
Conditions
Interventions
Intervention1: Applaud ELS System: It is intended to fragment urinary stones in patients having Urinary Stone Disease.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Applaud Medical Inc
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals presenting with minimum of one urinary stone measuring at least 3mm in at least one dimension apparent on a computed tomography (CT) scan within the last 14 days. 2. Males and females age 18yrs or above will be included. No preference will be given to gender, although men have a higher prevalence of stone disease than women. 3. Capable of giving informed consent, and willing to have the informed consent process videotaped 4. Maximum stone size and overall stone burden, as estimated by pre-operative CT, below prescribed thresholds for certain treatment protocol variant.
Exclusion criteria
Exclusion criteria: 1. Individuals under 18 years of age 2. Individuals with radiolucent stones 3. Individuals with stones in the lower pole of kidney [This exclusion criteria does not apply for patients to be treated by a PCNL variant] 4. Individuals not following up in the treating hospital 5. Individuals with history of cystinuria 6. Individuals with urine pH below 5.5 7. Individuals with untreated urinary tract infection 8. Women who are pregnant 9. Individuals with a coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician. 10. Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side 11. Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.) 12. [For patients to be treated by an ELS Ultrasound variant] Individuals with an estimated skin-to-stone distance greater than 13cm 13. [For patients to be treated by an ELS Laser variants or an ELS Ultrasound variant with general anaesthesia] Individuals with ASA score of 3 or greater general anaesthesia risk level 14. Known sensitivity to medications required for percutaneous nephrolithotomy, ureteroscopic procedures, cystoscopic procedures, and procedures entailing retrograde placement of material in the ureter, including but not limited to the following: sedative agents, general anaesthetics, topical anesthetics, and opioid analgesics (if patient is scheduled for specific procedure, eg, general anaesthesia) The following additional exclusion criteria will apply for those patients under consideration for the ELS-Laser PCNL variants: 15(C): Positive preoperative urine culture within 2 weeks prior to the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 1. Proportion of patients with Serious Device-Related AEs.Timepoint: Post Applaud ELS treatment till study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients that are stone-free 2. Change in pain score 3. Time to passage of stone fragments 4. Use and quantity of pain medicationTimepoint: Post Applaud ELS treatment till study completion;Proportion of patients that are stone-free. Post-Treatment time to passage of stone fragments Timepoint: Post one Applaud ELS treatment | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed