Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths

NCT07619456 | Completed FDA Device

• 1 other identifier: STUDY-25-00111
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Stone-Free Rate (SFR) on Postoperative CT Imaging

  4-8 weeks postoperatively

• Postoperative Pain Score (VAS)

  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

  30 days postoperatively

Study Arms (2)

Suctioning-UAS

EXPERIMENTAL

Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment.

Device: Suctioning-UAS

Non-suctioning-UAS

ACTIVE COMPARATOR

Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment.

Device: Non-suctioning-UAS

Interventions

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.

Suctioning-UAS

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.

Non-suctioning-UAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Mantu Gupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeon will not be blinded to the UAS type (suctioning vs. non-suctioning) but will be blinded to IRP measurements during the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: April 3, 2025
• Primary Completion: October 10, 2025
• Study Completion: December 5, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)