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Die klinische Studie NCT07225933 (REASON) für Urolithiasis, Nierenstein, Nierensteine ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System (REASON) 3.000 Multizentrisch Real-World-Daten Neuartig

Aktiv, nicht rekrutierend
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Die klinische Studie NCT07225933 (REASON) ist eine beobachtungsstudie zur Untersuchung von Urolithiasis, Nierenstein, Nierensteine und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 1. Februar 2024 und soll 3.000 Teilnehmer aufnehmen. Durchgeführt von Calyxo, Inc. ist der Abschluss für 1. September 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 10. November 2025 aktualisiert.
Kurzbeschreibung
This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.
Ausführliche Beschreibung
The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events lea...Mehr anzeigen
Offizieller Titel

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System

Erkrankungen
UrolithiasisNierensteinNierensteine
Weitere Studien-IDs
  • REASON
  • CP00005
NCT-Nummer
NCT07225933
Studienbeginn (tatsächlich)
2024-02-01
Zuletzt aktualisiert
2025-11-10
Studienende (vorauss.)
2026-09
Geplante Rekrutierung
3.000
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Stichwörter
SURE
FANS
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
CVAC® SYSTEM
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.
FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Stone free Status
Completed by reviewing any available standard of care post-procedure imaging
Post-Operative up to 90 Days
Intra- & Post-Operative Complications
Completed by reviewing data available for intra- and post-op complications
Intra- & Post-Operative up to 90 Days
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Subjects that had SURE procedure with CVAC System performed in the retrospective cohort
  • Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort

  • For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones
Calyxo, Inc. logoCalyxo, Inc.
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1 Studienstandorte in 1 Ländern

California

University of California San Diego (UCSD), La Jolla, California, 92093-0934, United States