Urinary Stone
Conditions
Keywords
lithotripsy, urinary stone
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 treated up to 2 times with the Enhanced Lithotripsy System and followed for 90 days after the last treatment session.
Interventions
Stone treatment with the Enhanced Lithotripsy System
Sponsors
Avvio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety) | 90 days | Incidence of Serious Device and/or Serious Procedure-Related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free status | 30 days | Proportion of study participants who are successfully treated \[absence of stones or with only clinically-insignificant remaining fragments\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain scoring | 30 days | Patient reported pain scores |
| Pain medication usage | 30 days | Collection of pain concomitant pain medications |
| Time to stone passage | 30 days | Evaluation of stone presence |
Countries
Australia
Outcome results
None listed