A clinical trial to study safety and efficacy of medical device known as "Enhanced Lithotripsy System†that breaks the urinary stones and helps in removing the stones from the urinary system.

Not yet recruiting

• Conditions: Calculus of kidney and ureter,

• Registration Number: CTRI/2017/07/008974
• Lead Sponsor: Applaud Medical Inc

Brief Summary

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|This is non-randomized, single-arm, unblinded study. Applaud Medical, Inc. has developed Enhanced Lithotripsy System which is a type of lithotripsy and is intended to help characterize recently developed stone fragmentation methods combining low-intensity extracorporeal acoustic energy sources with acoustic energy focusing (AEF) material placed around the stone.

The target patient populations is adult males and females aged 18years or above with urinary stone size upto 15mm or less as estimated by pre-operative CT scan. The study duration is approximately 1 year. Enrollment is expected to take place upto 2 months. Follow up is for 1 Month.

On Day 1, 2, 3 & 7 Follow up pain and pain medications to be assessed and AEs are evaluated. On Day-14 follow up, CT scan (non-contrast) to evaluate stone status, including size and location of remaining stone; physical exam; assess for pain and pain medications; evaluate for AEs. 30 days after last ELS procedure: Physical exam; Evaluate for adverse events (AEs); Serum creatinine (to re-assess renal function); Assessment of pain and pain medications; Assessment of AEs.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Individuals presenting with one urinary stone— apparent on a computed tomography (CT) scan within the last 14 days.
• 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.
• Capable of giving informed consent, and willing to have the informed consent process videotaped.
• Stone size, as estimated by pre-operative CT, with all dimensions 15 mm or less.

Exclusion Criteria

• Individuals under 18 years of age.
• Individuals with radiolucent stones.
• Individuals with stones in the lower pole of kidney.
• Individuals not following up in the treating hospital.
• Individuals with history of cystinuria.
• Individuals with urine pH below 5.5. 7.
• Individuals with untreated urinary tract infection.
• Individuals who are not willing to use adequate method of contraception during the study period.
• 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.
• Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side.
• Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.).
• 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.	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	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)

Trial Locations

Locations (1)

Muljibhai Patel Urological Hospital; 🇮🇳 Kheda, GUJARAT, India

Muljibhai Patel Urological Hospital

🇮🇳Kheda, GUJARAT, India

Dr Mahesh Ramanlal Desai

Principal investigator

91-9824028040

mrdesai@mpuh.org