UrolithiasisPhase 1/2NCT07786844
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)
A Phase 1/2 study testing Using irrigation fluid with a certain concentration of norepinephrine in people with Urolithiasis and Lithotripsy, run by Geriatric Hospital of Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urolithiasis, Lithotripsy
- What is being tested?
- Using irrigation fluid with a certain concentration of norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 30 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Geriatric Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Jing Zhao, PhD, +8615205197656, m18156836569@163.com
About this study
Official title: Hemostasis and Safety Analysis of Norepinephrine Irrigation Fluid in Su-FURS Combined With NPUAS Lithotripsy. (Su-FURS: Single-use Flexible Ureteroscope, NPUAS: Negative Pressure Ureteral Access Sheath)
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
- Being tested
- Using irrigation fluid with a certain concentration of norepinephrine
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using irrigation fluid with a certain concentration of norepinephrineDrug
- Treat with 4 mg/3 L norepinephrine (NE) irrigation fluid during su-fURS combined with NPUAS lithotripsy.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Using irrigation fluid with a certain concentration of norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration in irrigation fluid
Collect irrigation fluid samples before and after norepinephrine irrigation treatment, and measure the hemoglobin concentration in the irrigation fluid.
Measured: 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.
Measured: Periprocedural
Mean arterial pressure (MAP)
After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records
Measured: Periprocedural
Heart rate (HR)
After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.
Measured: Periprocedural
Secondary outcomes (4)
Safety-related discontinuation proportion (SRD)
The proportion of participants whose study intervention is prematurely terminated because of safety-related adverse events or safety concerns.
Measured: From initiation of study intervention up to completion of surgical procedure (within-operative period)
Concomitant medications(CMs)
Record the type, dosage, route, and duration of all concomitant medications administered to participants during the study, including medications for underlying diseases, peri-operative supportive drugs and rescue medications.
Measured: From initiation of study intervention up to completion of surgical procedure (within-operative period)
Incidence of adverse events（IAEs）
Incidence of all-cause adverse events occurring in participants after study, including peri-operative complications and post-operative adverse events.
Measured: From time of initial intervention through 8 hours post-procedure, assessed up to Post-operative Day 1
Stone clearance rate(SCR)
Proportion of participants achieving stone-free status, defined as no residual stones or residual stone fragments ≤2 mm on postoperative imaging examination.
Measured: 1 day after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start21 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geriatric Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuang Wu, Geriatric Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786844
- Sponsor's protocol ID
- NMUB20240127
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis and Safety Analysis of Norepinephrine Irrigation Fluid in Su-FURS Combined With NPUAS Lithotripsy. (Su-FURS: Single-use Flexible Ureteroscope, NPUAS: Negative Pressure Ureteral Access Sheath)
- ClinicalTrials.gov ID
- NCT07786844
- Acronym / sponsor ID
- NMUB20240127
- Conditions
- Urolithiasis, Lithotripsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Geriatric Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Using irrigation fluid with a certain concentration of norepinephrineAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using irrigation fluid with a certain concentration of norepinephrine1. 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. | Drug | Experimental Arm |
Primary outcome
Hemoglobin concentration in irrigation fluid
Time frame: Under identical operating conditions, the irrigation fluid was collected before and 3 minutes after treatment with 4 mg/3 L NE bitartrate irrigation fluid.
Collect irrigation fluid samples before and after norepinephrine irrigation treatment, and measure the hemoglobin concentration in the irrigation fluid.
Systolic blood pressure (SBP)
Time frame: Periprocedural
After treatment with NE irrigation fluid. Systolic blood pressure was obtained from anesthesia records.
Mean arterial pressure (MAP)
Time frame: Periprocedural
After treatment with NE irrigation fluid. Mean arterial pressure (MAP) was obtained from anesthesia records
Heart rate (HR)
Time frame: Periprocedural
After treatment with NE irrigation fluid. Heart rate (HR) was obtained from anesthesia records.
4 secondary outcomes
Safety-related discontinuation proportion (SRD)
Time frame: From initiation of study intervention up to completion of surgical procedure (within-operative period)
Concomitant medications(CMs)
Time frame: From initiation of study intervention up to completion of surgical procedure (within-operative period)
Incidence of adverse events（IAEs）
Time frame: From time of initial intervention through 8 hours post-procedure, assessed up to Post-operative Day 1
Stone clearance rate(SCR)
Time frame: 1 day after surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Using irrigation fluid with a certain concentration of norepinephrine in people with Urolithiasis and Lithotripsy, run by Geriatric Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuang Wu, Doctor of Medicine (+8618156836569, 813131618@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration in irrigation fluid (time frame: Under identical operating conditions, the irrigation fluid was collected before and 3 minutes after treatment with 4 mg/3 L NE bitartrate irrigation fluid.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.