Health Condition 1: N20- Calculus of kidney and ureter
Conditions
Interventions
Intervention1: ELS: It is intended to fragment kidney 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 one urinary stoneâ?? apparent on a computed tomography (CT) scan within the last 14 days. 2. Males and females aged 18 or older 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. Stone size, as estimated by pre-operative CT, with all dimensions 15 mm or less.
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. 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. Individuals who are not willing to use adequate method of contraception during the study period. 9. Women who are pregnant, lactating or planning pregnancy during the study period. 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. Individuals with a BMI greater than 35. 13. Individuals with ASA score of 3 or greater general anesthesia risk level 14. Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Proportion of patients with Serious Device-Related AEs.Timepoint: After EOS visit (Day 30 post last ELS treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who are successfully treated following up to two ELS treatments 2. Change in pain score after one ELS treatment-- Pain score at different visits would be compared from baseline visit using paired t test or Wilcoxon signed-rank test (whichever appropriate) 3. Post-Treatment time to passage of stone fragments-- Post-treatment time to passage of stone fragments will be analyzed using Kaplan-Meier time-to-event methods 4. Use and quantity of pain medicationTimepoint: After EOS visit (Day 30 post last ELS treatment | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed