Kidney Stones, Nephrolithiasis, Urolithiasis
Conditions
Keywords
kidney stones, medical device, Urological procedure
Brief summary
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
Interventions
DEVICERIRS with Investigational Device
Investigational endourological device used during retrograde intrarenal surgery.
Sponsors
Ventaris Surgical Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of calyceal and/or renal pelvis calculi 2. Age from 18 through 85 years 3. Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment 4. Willing and able to comply with all study requirements 5. Signs study-specific informed consent form
Exclusion criteria
1. Diagnosis of calculus of the ureter 2. BMI ≥ 42 3. Significant renal impairment: stage 3a CKD or higher (eGFR \<59mL/min) 4. Active infection, including urinary tract infection 5. Urological anatomic/congenital abnormalities 6. Previous history of struvite stone in the same renal unit 7. Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d) 8. History of gross hematuria 9. Solitary functioning kidney 10. Known allergy to device materials 11. Any severe illness that would prevent complete study participation or confound study results 12. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure - NYHA Class IV), pulmonary disease or uncontrolled diabetes. 13. History of open-heart surgery, or cardiac arrest \< 180 days prior to the date of informed consent 14. ASA III or higher 15. Taking systemic immune suppressants 16. Dementia or psychiatric condition that prevents the participant from completing required follow up 17. Contraindication to both general and spinal anesthesia 18. Participating in another investigational study that could affect responses to the study device 19. Unwilling to accept a transfusion should one be required 20. Pregnant or considering getting pregnant within the next 3 months 21. Undergoing bilateral ureteroscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | Intraoperative | Successful completion of the planned procedure without device-related technical complications. |
| Serious Adverse Device Effects (SADEs) | 30 days post-procedure | Serious adverse device effects related to the investigational device. |
| Stone-Free Status | 30 days post-procedure | Absence of residual stone fragments on CT imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Categories | 30 days post-procedure | Stone-free status according to predefined categories. |
| Intrarenal pressure assessment | Intraoperative | Intrarenal pressure measured during the procedure. |
| Procedure duration | Intraoperative | Duration of the surgical procedure. |
| Stone clearance | Intraoperative | Amount of stone material removed during the procedure. |
| Residual stone burden | 30 days post-procedure | Residual stone burden assessed by imaging. |
| Device- or procedure-related adverse event | From procedure to 12 months post-procedure | Device- or procedure-related adverse event. |
| Stone-related healthcare utilization | From procedure to 12 months post-procedure | Healthcare utilization related to recurrent stone symptoms in the treated kidney. |
Countries
Argentina, Canada, Hong Kong, India, New Zealand
Contacts
CONTACTMatt Sprinkel
Outcome results
None listed