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Purpose <p>To evaluate the safety and clinical performance of a fluid-management system with intrarenal pressure management during flexible ureteroscopy in patients with renal or ureteral stones.</p> Methods <p>prospective, observational, descriptive study at two centers in Santiago, Chile, from April to June 2025. Adults (≥ 18 years) with confirmed upper urinary tract stones undergoing flexible ureteroscopy were included (<i>n</i> = 14). Exclusion criteria comprised active urinary infection, significant anatomical abnormalities, pregnancy or lactation. All procedures employed a single-use LithoVue Elite ureteroscope integrated with Asurys. Continuous intrarenal pressure measurements were recorded, with the Asurys system configured in <i>LithoVue Elite Mode</i> using a target pressure limit of 25–35 cmH₂O (18.4–25.8 mmHg) (flow limiter) and adjustable flush limiter (typically 80–100 cmH₂O (58.8–73.6 mmHg)). Intraoperative parameters, including operative time, laser usage, and instrument sheath utilization, were documented. Postoperative complications were classified by Clavien‐Dindo. Laboratory values (e.g., C‐reactive protein, fibrinogen, creatinine) were obtained preoperatively and 2–3&#xa0;h postoperatively.</p> Results <p>The mean age was 51 years, 78% were male. Stones had a median diameter of 8&#xa0;mm and a median volume of 189.9&#xa0;mm³. Median operative time was 60&#xa0;min (range 50.0-90.5). The mean intrarenal pressure was 29 ± 13 cmH₂O (21.3 ± 9.6 mmHg). One patient (7%) experienced a Clavien‐Dindo II urinary tract infection; one (7%) had grade I pain.</p> Conclusion <p>Asurys was associated with low complication rates and high surgeon satisfaction, suggesting that automated pressure control is safe and effective during flexible ureteroscopy.</p>

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Automated intrarenal pressure control in flexible ureteroscopy using an integrated ureteroscope pressure measurement and fluid management system: first-in‐human use

  • 期刊论文

  • 发表日期：

    2025年12月15日

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  • Juan Fulla,
  • Francisca Larenas,
  • Diego Saldivia,
  • Helga Ibañez,
  • Vicente Elorrieta,
  • Catherine Sanchez,
  • José A. Salvadó

摘要

Purpose

To evaluate the safety and clinical performance of a fluid-management system with intrarenal pressure management during flexible ureteroscopy in patients with renal or ureteral stones.

Methods

prospective, observational, descriptive study at two centers in Santiago, Chile, from April to June 2025. Adults (≥ 18 years) with confirmed upper urinary tract stones undergoing flexible ureteroscopy were included (n = 14). Exclusion criteria comprised active urinary infection, significant anatomical abnormalities, pregnancy or lactation. All procedures employed a single-use LithoVue Elite ureteroscope integrated with Asurys. Continuous intrarenal pressure measurements were recorded, with the Asurys system configured in LithoVue Elite Mode using a target pressure limit of 25–35 cmH₂O (18.4–25.8 mmHg) (flow limiter) and adjustable flush limiter (typically 80–100 cmH₂O (58.8–73.6 mmHg)). Intraoperative parameters, including operative time, laser usage, and instrument sheath utilization, were documented. Postoperative complications were classified by Clavien‐Dindo. Laboratory values (e.g., C‐reactive protein, fibrinogen, creatinine) were obtained preoperatively and 2–3 h postoperatively.

Results

The mean age was 51 years, 78% were male. Stones had a median diameter of 8 mm and a median volume of 189.9 mm³. Median operative time was 60 min (range 50.0-90.5). The mean intrarenal pressure was 29 ± 13 cmH₂O (21.3 ± 9.6 mmHg). One patient (7%) experienced a Clavien‐Dindo II urinary tract infection; one (7%) had grade I pain.

Conclusion

Asurys was associated with low complication rates and high surgeon satisfaction, suggesting that automated pressure control is safe and effective during flexible ureteroscopy.