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A Study on the Application of NE Irrigation Fluid for Hemostasis in Flexible Ureteroscopic Lithotripsy: A Prospective Single-arm Interventional Study of Upper Urinary Tract Calculi.(NE: Norepinephrine)

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllGeriatric Hospital of Nanjing Medical University
NCT07786844 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Urinary stone disease is globally prevalent with rising incidence and recurrence, imposing heavy socioeconomic burdens. Flexible ureteroscopy has advanced stone treatment. Single-use flexible ureteroscopes (su-fURS) combined with negative pressure ureteral access sheath (NPUAS), recommended by urology guidelines, improve surgical safety and stone-free rates and can treat stones โ‰ค3 cm. However, su-fURS has poorer image quality, bleeding during lithotripsy may blur vision, frequently impairing efficiency and safety. Norepinephrine (NE), a tyrosine-derived sympathomimetic amine, mainly activates ฮฑ1 and ฮฒ1 receptors. Doses above 3 ฮผg/min trigger predominant ฮฑ1-mediated vasoconstriction of arteries and veins. It can act on mucosal surfaces via irrigation fluid, making it favorable for initial hemostasis of injured mucosa. Firstly, this study aims to evaluate the efficacy and safety of low-co

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Age 18-75 years of either sex. * Clinically and radiologically confirmed renal or upper-ureteral stone with operative indication for super flexible ureteroscopic lithotripsy combined with negative pressure ultrasound lithotripsy (su-fURS + NPUAS). * Subjects with definite surgical indication for upper urinary tract stones, tolerate general anesthesia, and agree to receive the targeted operative procedure. Exclusion Criteria * Diagnosis of non-upper urinary tract stones. * Intolerance to flexible ureteroscopic surgery. * Poorly-controlled hypertension with blood pressure greater than 160/100 mmHg. * History of coronary artery disease.
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What it tests

  • Using irrigation fluid with a certain concentration of norepinephrine
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Where

1 site
Geriatric Hospital of Nanjing Medical University
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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