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
Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety. A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP. Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates. However, IRP during suctioning procedures has yet to be thoroughly investigated. The aim of this study is to compare the IRP during fURS using UAS with and without suctioning technique.
Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety. With advances in technology, precise tools like the LithoVueâ„¢ Elite now enables continuous IRP measurement, facilitating accurate data collection throughout the procedure. A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP. Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates (SFR). However, IRP during suctioning procedures has yet to be thoroughly investigated. This study is a randomized controlled trial comparing continuous intrarenal pressure (IRP) measurements during flexible ureteroscopy (fURS) using a suctioning ureteral access sheath (UAS) versus a non-suctioning UAS. The study will be conducted over an 18-month period and will include all patients over 18 years of age who are scheduled to undergo fURS for a stone burden greater than 1 cm and/or multiple stones. Patients who are pregnant, have an untreated urinary tract infection (UTI), urinary tract anomalies such as urinary diversion, ureteral reconstruction, or horseshoe kidney, or who have a single stone smaller than 1 cm will be excluded from participation. All procedures will take place at Mount Sinai West, with patients enrolled from the practices of two endourology-trained specialists, Dr. William Atallah and Dr. Mantu Gupta. Participants will be randomized to either the suctioning-UAS arm using the ClearPETRA Flexible and Navigable Suction UAS or the non-suctioning-UAS arm using the BSC Navigator device.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suctioning-UAS | Experimental | Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment. |
|
| Non-suctioning-UAS | Active Comparator | Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suctioning-UAS | Device | Participants undergoing flexible ureteroscopy (fURS) will receive a suctioning ureteral access sheath using the ClearPETRA Flexible and Navigable Suction UAS. Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrarenal Pressure (IRP) During Flexible Ureteroscopy | Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system. | Intraoperative (during procedure) |
| Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy | Time spent above Intrarenal Pressure (IRP) thresholds of 20, 40, 60, 80, and 100 mmHg using the LithoVue Elite ureteroscope system. | Intraoperative (during procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-Free Rate (SFR) on Postoperative CT Imaging | Rate of stone-free status assessed by non-contrast CT scan using a 4-grade scale (Grade A: completely stone-free; Grade B: residual fragments <2 mm; Grade C: residual fragments 2-4 mm; Grade D: residual fragments >4 mm). | 4-8 weeks postoperatively |
| Postoperative Pain Score (VAS) |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mantu Gupta, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | United States |
To to protect participant privacy
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Surgeon will not be blinded to the UAS type (suctioning vs. non-suctioning) but will be blinded to IRP measurements during the procedure.
|
| Non-suctioning-UAS | Device | Participants undergoing flexible ureteroscopy (fURS) will receive a standard non-suctioning ureteral access sheath using the BSC Navigator device. Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system. |
|
Visual Analog Scale (VAS) pain score. Scale ranges from 0 (no pain) to 10 (worst pain imaginable); higher scores indicate greater pain intensity. |
| In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively) |
| Number of Postoperative Complications | Number of any postoperative complications occurring within 30 days of the procedure (as defined by the study protocol and standard Clavien-Dindo classification or similar). | 30 days postoperatively |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |