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)

NCT07786844 | Recruiting Phase 1 DMC

• 1 other identifier: NMUB20240127
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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 ≤3 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 α1 and β1 receptors. Doses above 3 μg/min trigger predominant α1-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-concentration norepinephrine (NE) irrigation solution for hemostasis during lithotripsy performed with single-use flexible ureteroscope (su-fURS) combined with NPUAS, fifteen subjects will be enrolled in the study. Secondly, we explore the dose-effect relationships of four concentrations: 2 mg/3 L, 4 mg/3 L, 6 mg/3 L and 8 mg/3 L, and determine the optimal concentration by comprehensively evaluating hemostatic efficacy and safety. A total of 40 subjects will be enrolled, with 10 subjects in each concentration.

Conditions

Urolithiasis; Lithotripsy

Outcome Measures

Primary Outcomes (4)

• Hemoglobin concentration in irrigation fluid

  Collect irrigation fluid samples before and after norepinephrine irrigation treatment, and measure the hemoglobin concentration in the irrigation fluid.

  Under identical operating conditions, the irrigation fluid was collected before and 3 minutes after treatment with 4 mg/3 L NE bitartrate irrigation fluid.

• Systolic blood pressure (SBP)

  After treatment with NE irrigation fluid. Systolic blood pressure was obtained from anesthesia records.

  Periprocedural

• Mean arterial pressure (MAP)

  After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records

  Periprocedural

• Heart rate (HR)

  After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.

  Periprocedural

Secondary Outcomes (4)

• Safety-related discontinuation proportion (SRD)

  From initiation of study intervention up to completion of surgical procedure (within-operative period)

• Concomitant medications(CMs)

  From initiation of study intervention up to completion of surgical procedure (within-operative period)

• Incidence of adverse events（IAEs）

  From time of initial intervention through 8 hours post-procedure, assessed up to Post-operative Day 1

• Stone clearance rate(SCR)

  1 day after surgical procedure

Study Arms (1)

Experimental Arm

EXPERIMENTAL

All enrolled participants receive lithotripsy with single-use flexible ureteroscope combined with negative pressure ureteral access sheath (NPUAS) for upper urinary tract calculi, standard normal saline irrigation fluid is used for flushing first, followed by treatment with irrigation fluid with a certain concentration of norepinephrine.

Drug: Using irrigation fluid with a certain concentration of norepinephrine

Interventions

Using irrigation fluid with a certain concentration of norepinephrine DRUG

1. Treat with 4 mg/3 L norepinephrine (NE) irrigation fluid during su-fURS combined with NPUAS lithotripsy. 2. Treat with different concentrations of norepinephrine irrigation fluid (2 mg/3 L, 4 mg/3 L, 6 mg/3 L, 8 mg/3 L) when lithotripsy.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geriatric Hospital of Nanjing Medical University: lead

Study Sites (1)

Geriatric Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Chuang Wu, Doctor of Medicine

CONTACT

+8618156836569; 813131618@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 26, 2026
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)