Urinary Stone
Conditions
Keywords
lithotripsy, urinary stone, urolithiasis
Brief summary
This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeally induced 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 extracorporeally induced 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
Treatment of urinary stone disease 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
1. Male or female aged ≥ 18 years 2. Provides written informed consent 3. Understands and accepts the study requirements 4. One urinary stone eligible for treatment (minimum) that is: 1. apparent on a computed tomography (CT) scan within 14 days prior to study enrollment 2. located within the renal pelvis or ureter 3. is ≥ 3 mm in at least one dimension and ≤ 10 mm in maximum 4. less than or equal to 10mm in maximum dimension and has an area less than 56mm2 as estimated by pre-procedure CT dimension as estimated by pre- procedure CT 5. Participants with two or more stones in one or both kidneys are admissible and must meet the following inclusion criteria: 1. Number of stones (≥ 3 mm) present on treated side is 2 or less 2. Untreated stones must not be anticipated to require treatment within 30 days of enrollment, as determined by the investigator
Exclusion criteria
1. Age less than 18 years of age or over 75 years of age 2. Diagnosis of radiolucent stones 3. History of cystinuria 4. Urine pH below 5.5 5. Current untreated urinary tract infection 6. Pregnancy 7. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 8. Enrollment in another research study or previous participation within 30 days of enrollment. 9. Participant has planned general anesthesia during index procedure with American Society of Anesthesiologists (ASA) physical classification level of 3 or greater 10. 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 11. Coagulation abnormality or taking prescription anticoagulants that cannot be stopped during treatment. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician 12. Mobility issues - unable to comfortably lie still for up to 120 minutes or unable to roll from back to side 13. Known hypersensitivity to conductivity gel 14. Body mass index (BMI) ≥ 35 unless anticipated skin to stone distance (anticipated distance from site of ELS treatment head to stone per pre-operative CT) is \<135mm 15. Implanted spinal cord neurostimulator intrathecal pump or any device that may interfere with energy transmission 16. Participant has open wounds, lesions, dermatitis, or ischemic tissues in the treatment area 17. Participant has had a major surgery that removed tissue around the spinal cord (e.g. a laminectomy) within the treatment area 18. Participant will undergo treatment of a stone located in the distal ureter and has previous hernia repair or surgical mesh implanted in the inguinal/hypogastric regions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success | 30 days | Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety) | 30 days | Incidence of Serious Device and/or Serious Procedure-Related adverse events |
Countries
Australia
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 50.3 years |
| BMI | 28.79 kg/m^2 |
| Region of Enrollment Australia | 25 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 12 / 25 |
| serious Total, serious adverse events | 4 / 25 |
Outcome results
None listed