Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths

Comparing the Intrarenal Pressure Between Suctioning and Non-Suctioning Access Sheaths Using the LithoVue Elite Ureteroscope System

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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis
• Intervention / Treatment: Device: Suctioning-UAS; Device: Non-suctioning-UAS

Detailed Description

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 LithoVue™ 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

• Adults aged 18 years and older.
• Diagnosed with kidney stones and scheduled for fURS.
• Stone burden > 1 cm and/or multiple stones will be eligible.
• Able and willing to provide informed consent.

EXCLUSION CRITERIA

• Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at our institution)
• Untreated UTI
• Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
• Single stone < 1 cm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suctioning-UAS; Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment.	Device: Suctioning-UAS; 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.
Active Comparator: Non-suctioning-UAS; Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment.	Device: Non-suctioning-UAS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mantu Gupta, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis
• Other Study ID Numbers: STUDY-25-00111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To to protect participant privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No