Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Study Overview
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Brief Summary
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This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

Detailed Description
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This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 30 days after the last treatment session.

Official Title
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Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Conditions
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Urinary Stone

Intervention / Treatment
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* Device: Enhanced Lithotripsy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days Males and females aged 18 or older Capable of giving informed consent, and willing to have the informed consent process videotaped Stone size, as estimated by pre-operative computed tomography, 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 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. 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 a body mass index greater than 35 Individuals with ASA score of 3 or greater general anesthesia risk level Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm trial with the Enhanced Lithotripsy System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Lithotripsy System<br>Treatment for urinary stones with the Enhanced Lithotripsy System | Device: Enhanced Lithotripsy System<br>* The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with serious device-related adverse events (safety) | Safety: Proportion of subjects with serious device-related adverse events | 30 days after last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful treatment of urinary stone | Proportion of subjects with successful treatment or urinary stone | 14 days after last treatment session |