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This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRP-Monitoring FANS Group | Experimental | Patients in this group will undergo retrograde intrarenal surgery (RIRS) using the intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS). This novel device provides real-time IRP monitoring, enabling the surgeon to adjust intraoperative irrigation and suction settings to optimize stone retrieval efficiency while maintaining IRP within a safe range. |
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| Conventional FANS Group | Active Comparator | Patients in this group will undergo RIRS using a conventional flexible and navigable suction ureteral access sheath (FANS) without intrarenal pressure (IRP) monitoring. The irrigation flow rate and suction pressure will be pre-set and adjusted based on standard clinical practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) | Device | The IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a novel device designed to enable real-time monitoring of intrarenal pressure (IRP) during retrograde intrarenal surgery (RIRS). It incorporates a pressure-sensing port connected to a gas conduit embedded in the sheath, which allows the surgeon to adjust irrigation flow and suction pressure based on real-time IRP readings, thereby optimizing stone retrieval efficiency while ensuring safety by maintaining a safe IRP range. The device improves surgical outcomes, particularly in complex cases involving larger renal stones, by reducing operative time and minimizing the risk of complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS. | Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient). |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-Free Rate (SFR) | The stone-free rate (SFR) will be measured postoperatively through non-contrast CT imaging. The SFR will assess the effectiveness of stone retrieval and the success of the procedure. | 24-48 hours post-surgery, based on CT scan results. |
| Postoperative Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guohua Zeng | Guangzhou | Guangdong | 510230 | China |
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| Conventional FANS | Device | The Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a standard device used in retrograde intrarenal surgery (RIRS) for stone retrieval. Unlike the IRP-monitoring version, this device does not provide real-time monitoring of intrarenal pressure (IRP). Irrigation flow and suction pressure are pre-set and adjusted based on clinical protocols. It facilitates the removal of renal stones through a flexible and navigable design, but without the added capability of monitoring and adjusting IRP during the procedure. |
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The rate of postoperative complications, including fever, infection, bleeding, or ureteral injury, will be recorded. This will help compare the safety profile of both FANS devices. |
| Evaluated within 30 days post-surgery. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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