Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL).
The main questions it aims to answer are:
How many participants are stone-free within 24 hours after surgery?
How many participants are stone-free 1 month after surgery?
What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL?
Does VISOR help keep kidney pressure stable during surgery?
Researchers will compare VISOR to PCNL to see which treatment works better and is safer.
Participants will:
Be randomly assigned to have surgery with either VISOR or PCNL.
Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared.
Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging.
About 170 people will take part in this study at cooperative hospitals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: VISOR | Experimental | Participants will undergo Vortex Intelligence Stone Optimized Removal. |
|
| PCNL Group | Active Comparator | Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortex Intelligence Stone Optimized Removal | Procedure | Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate within 24 hours | The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate at 1 month | The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound. | 28 ± 7 days after surgery |
| Operative Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bohan Wang, MD., Ph.D | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 230000 | China |
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074642 | Nephrolithotomy, Percutaneous |
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percutaneous Nephrolithotomy (PCNL) | Procedure | A standard PCNL technique will be performed according to institutional practice guidelines. |
|
Total time from the beginning to the end of the surgery, measured in minutes.
| During surgery (Day 0) |
| Postoperative fever | Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery. | 0-30 days after surgery |
| Postoperative ureteral stricture | Occurrence of ureteral narrowing detected by imaging within 1 month after surgery. | 28 ± 7 days after surgery |
| Pain assessment (VAS score) | Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively. | Postoperative Day 0-28 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |