Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07619456
Status
Completed

Conditions

  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 3, 2025
Status verified
May 2026
Primary completion
Oct 10, 2025
Completion
Dec 5, 2025

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suctioning-UAS
    Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment.
  • Active Comparator: Non-suctioning-UAS
    Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment.

Primary Outcome Measure

Intrarenal Pressure (IRP) During Flexible Ureteroscopy [ Time Frame: Intraoperative (during procedure) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019-

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By research site
Mount Sinai West· New York, NY

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