Urinary Stone
Conditions
Brief summary
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.
Detailed 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.
Interventions
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
Sponsors
Avvio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single arm trial with the Enhanced Lithotripsy System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with serious device-related adverse events (safety) | 30 days after last treatment session | Safety: Proportion of subjects with serious device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful treatment of urinary stone | 14 days after last treatment session | Proportion of subjects with successful treatment or urinary stone |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score | Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30 | Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain |
| Time to passage of stones | 30 days after last treatment session | Post-Treatment time to passage of stone fragments after treatment |
| Pain medication usage | Baseline and Days 1, 2, 3, 7, 14, and 30 | Use and quantity of pain medication |
Countries
India
Outcome results
None listed