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A multi-center study on the clinical efficacy and safety of the disposable, electronic, flexible ureteroscope

A multi-center study on the clinical efficacy and safety of the disposable, electronic, flexible ureteroscope

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015841
Enrollment
Unknown
Registered
2018-04-24
Start date
2018-04-26
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Urinary Calculi

Interventions

trial group:Zhuhai Pusen disposable, electronic, flexible ureteroscope
control group:German KARL STORZ fiberoptic flexible ureteroscope

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) aged 18~60 years male and female; (2) by color Doppler ultrasound, X-ray or CT examination, the upper ureteral calculi or renal calculi is =2cm ,or proved to have multiple stones in single kidney and the largest diameter was more than 2cm; (3) preoperative urinary tract infection has been controlled: stones with infection and fever should be treated with antibotics till a normal body temperature for at least 3 days; (4) organ function must meet the following requirements: Bone marrow: blood routine results showed that hemoglobin was more than 90g/L, platelets were more than 100x10^9/L, and the absolute count of neutrophils was more than 1.5x10^9/L; Liver: serum bilirubin is less than 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase are less than 2.5 times the normal upper limit; Kidney: the upper limit of normal value of serum creatinine was less than 1.25 times; (5) for women with fertility, effective contraceptive measures are used for at least 1 months before screening, and the use of such measures during the whole period of the study is agreed; (6) the subjects indicated that they were willing to complete all the steps and the research intervention cycle in the study; (7) to provide a signed and dated informed consent.

Exclusion criteria

Exclusion criteria: (1) the affected side is associated with urinary malformations, such as ureteropelvic junction obstruction, ureteral stricture and so on; (2) pyelography or CT examination confirmed that the body of the stone was located in the renal calyx diverticulum; (3) pyelography or CT examination showed that the main body of the stone was located in the lower renal calyx and the angle of the renal pelvis was less than 30 degrees; (4) patients with renal insufficiency; (5) pregnancy or lactation; (6) lung function tests showed moderate or above lung function impairment in patients with severe lung disease, asthma or COPD history; (7) diagnosed as bleeding or hypercoagulability; (8) subjects were enrolled in another experimental instrument, drug or biological research; (9) any unstable or possible condition for the safety of the subjects and their compliance with the study, or the researchers believe that the subjects have any other factors that are not appropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
video quality fine rate;

Secondary

MeasureTime frame
lithotripsy success rate;

Countries

China

Contacts

Public ContactWu Rongpei

The First Affiliated Hospital of Sun Yat-sen University

pacemaker_wrp@163.com+86 13570598905

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026