Enhanced Lithotripsy System (ELS) 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

NCT03339388

2017-03

Details and patient eligibility

About

This is a single arm, multi-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, multi-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 90 days after the last treatment session.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged ≥ 18 years to ≤ 75 years.
One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
Provides written informed consent
Understands and accepts the study requirements

Exclusion criteria

Age less than 18 years of age or over 75 years of age
Diagnosis of radiolucent stones
Diagnosis of stones in the lower pole of kidney
History of cystinuria
Urine pH below 5.5
Current untreated urinary tract infection
Pregnancy
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.
Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to roll from back to side
Known hypersensitivity to conductivity gel
Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
Body mass index greater than 35
American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics.
Enrollment in another research study or previous participation within 30 days of enrollment.