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

Applaud Medical

Status

Terminated

Conditions

Urinary Stone

Treatments

Device: Enhanced Lithotripsy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03195920

2017-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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