Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study

Официальное название

Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Other Therapeutic Interventions for the Treatment of Renal Stones: a Prospective, Observational Trial

Обзор

The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other commonly used renal-stone interventions.

Подробное описание

Up to 25 sites, and up to 250 subjects will be prospectively enrolled for phase 1: CVAC and FANS cohorts.

Вмешательства

• Устройство 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).
• Устройство FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
  Group/Cohort Description: 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.
• Устройство DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)
  DISS is a system that integrates controlled suction into the working channel of a standard flexible ureteroscope during ureteroscopic lithotripsy. A suction adapter is attached externally to the ureteroscope's working port, which connects to a standard hospital suction source.
• Процедура URETEROSCOPY (URS) WITHOUT SUCTION
  URS allows the surgeon to visualize the stone by inserting the ureteroscope into the ureter, most often a flexible scope that allows them to accommodate to the shape of the ureter and renal collecting system. A laser fiber is advanced through the working channel of the ureteroscope to perform stone fragmentation (dusting or breaking up the calculi). Once the stones are dusted or fragmented, the pieces can be removed by active extraction of individual stone fragments using a retrieval basket or u
• Процедура PERCUTANEOUS NEPHROLITHOTOMY (PCNL)
  This is a surgical procedure under general anesthesia, where a rigid probe is placed through the flank, creating a percutaneous tract into the renal collecting system under fluoroscopy. Via nephoscopy, stones are fragmented, pulverized, and extracted.

Первичные конечные точки

• Residual Stone Volume (RSV) [Срок оценки: 30-Day]

Критерии участия

Критерии включения

• Candidate for ureteroscopy with laser lithotripsy or PCNL for the treatment of renal stones
• Be willing and able to return for and respond to all study-related follow up procedures
• Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Критерии исключения

• Untreated urinary tract infection at the time of the index procedure
• Visual evidence of infection at the time of the index procedure
• History of sepsis
• Significant comorbidities
• Bladder, ureteral or kidney abnormalities
• Pregnant individuals
• Unable to meet the treatment and follow up protocol requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07155005 · CP00007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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