A clinical trial to study safety and efficacy of medical device known as Enhanced Lithotripsy Systemâ?? that breaks the urinary stones and helps in removing the stones from the urinary system.
- Conditions
- Health Condition 1: N20- Calculus of kidney and ureter
- Registration Number
- CTRI/2017/07/008974
- Lead Sponsor
- Applaud Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Proportion of patients with Serious Device-Related AEs.Timepoint: After EOS visit (Day 30 post last ELS treatment
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients who are successfully treated following up to two ELS treatments <br/ ><br>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) <br/ ><br>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 <br/ ><br>4. Use and quantity of pain medicationTimepoint: After EOS visit (Day 30 post last ELS treatment