Status:
TERMINATED
Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
Lead Sponsor:
Avvio Medical
Conditions:
Urinary Stone
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed 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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03339388
Start Date
December 8 2017
End Date
October 5 2022
Last Update
April 17 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
McArthur Urology
Campbelltown, New South Wales, Australia, 2560
2
Westmead Private Hospital
Westmead, New South Wales, Australia, 2145
3
Goldfields Urology
Bendigo, Victoria, Australia, 3550
4
Austin Health
Melbourne, Victoria, Australia, 3084