Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT07159503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-12
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VISOR Versus PCNL for Treatment of 2-4cm Renal Stones
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: