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A prospective, multicenter, randomized, controlled, non-inferiority clinical study evaluating the efficacy and safety of disposable ureteropelvic imaging catheters for observation, diagnosis, imaging, and device-assisted therapy of the ureter and renal pelvis

A prospective, multicenter, randomized, controlled, non-inferiority clinical study evaluating the efficacy and safety of disposable ureteropelvic imaging catheters for observation, diagnosis, imaging, and device-assisted therapy of the ureter and renal pelvis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057046
Enrollment
Unknown
Registered
2022-02-26
Start date
2018-11-19
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Observation, diagnosis, imaging and device-assisted treatment of ureter and renal pelvis

Interventions

Experimental group:Observation, diagnosis, imaging and device-assisted treatment of ureter and renal pelvis
Control group:Observation, diagnosis, imaging and device-assisted treatment of ureter and renal pelvis

Sponsors

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent; 2. Age 18-70 years old (including 18 and 70 years old), male or female; 3. Kidney or/and ureteral calculi (positive) diagnosed by urinary system plain film (KUB), suitable for flexible lithotripsy; 4. The diameter of kidney or/and ureter positive stones is less than or equal to 2cm; 5. Indwelling DJ tube (Double-J stent, double-J tube) 2-4 weeks before surgery.

Exclusion criteria

Exclusion criteria: 1. The patient is participating in another drug or medical device clinical trial; 2. Patients with severe cardiopulmonary insufficiency who cannot tolerate surgery; 3. Patients with severe urinary tract infections; 4. Those with abnormal coagulation function; 5. Severe urethral or ureteral stricture, severe deformity, and abnormal renal anatomy; 6. Females of childbearing age have positive blood pregnancy tests, and lactating females; 7. Those with uncorrected diabetes and hypertension; 8. Those with stones in the calyceal diverticulum; 9. Other investigators believe that it may hinder the evaluation of the results or constitute a risk to the subject's health.

Design outcomes

Primary

MeasureTime frame
Intraoperative image quality excellent rate;

Secondary

MeasureTime frame
Average operation time;Device performance;

Countries

China

Contacts

Public ContactTang Wei

Shanghai AnQing Medical instrument Co., Ltd

tony.tang@anqing-sh.com+86 13641619582

Outcome results

None listed

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