- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07619456
Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths
26 maj 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
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New York, New York, Förenta staterna, 10019
- Mount Sinai West
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intrarenal Pressure (IRP) During Flexible Ureteroscopy
Tidsram: Intraoperative (during procedure)
|
Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system.
|
Intraoperative (during procedure)
|
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Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stone-Free Rate (SFR) on Postoperative CT Imaging
Tidsram: 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
|
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Postoperative Pain Score (VAS)
Tidsram: 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)
|
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Number of Postoperative Complications
Tidsram: 30 days postoperatively
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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).
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30 days postoperatively
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 april 2025
Primärt slutförande (Faktisk)
10 oktober 2025
Avslutad studie (Faktisk)
5 december 2025
Studieregistreringsdatum
Först inskickad
26 maj 2026
Först inskickad som uppfyllde QC-kriterierna
26 maj 2026
Första postat (Faktisk)
2 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY-25-00111
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
To to protect participant privacy
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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