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Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths

26. mai 2026 oppdatert av: Mantu Gupta, Icahn School of Medicine at Mount Sinai

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • New York, New York, Forente stater, 10019
        • Mount Sinai West

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Suctioning-UAS
Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment.
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.
Aktiv komparator: Non-suctioning-UAS
Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intrarenal Pressure (IRP) During Flexible Ureteroscopy
Tidsramme: Intraoperative (during procedure)
Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system.
Intraoperative (during procedure)
Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy
Tidsramme: Intraoperative (during procedure)
Time spent above Intrarenal Pressure (IRP) thresholds of 20, 40, 60, 80, and 100 mmHg using the LithoVue Elite ureteroscope system.
Intraoperative (during procedure)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stone-Free Rate (SFR) on Postoperative CT Imaging
Tidsramme: 4-8 weeks postoperatively
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)
Tidsramme: In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively)
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
Tidsramme: 30 days postoperatively
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. april 2025

Primær fullføring (Faktiske)

10. oktober 2025

Studiet fullført (Faktiske)

5. desember 2025

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

To to protect participant privacy

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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