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A clinical trial of Multicenter, randomized, open, parallel, non-inferior to evaluate the safety and efficacy of disposable ureteral imaging catheters and ureteral imaging host systems

A clinical trial of Multicenter, randomized, open, parallel, non-inferior to evaluate the safety and efficacy of disposable ureteral imaging catheters and ureteral imaging host systems

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021615
Enrollment
Unknown
Registered
2019-03-01
Start date
2018-08-10
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Urinary system disease

Interventions

Experimental group:Diagnosis and treatment of subjects using a disposable ureteral imaging catheter and ureter imaging host system
Control group:Electronic Ureteroperitoneoscope and Endoscopic Camera System Produced by Olympus Medical Company

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients requiring ureteroscopy or treatment for urinary system diseases; 2. For subjects with lesions of stones, considering the need to divide the gravel, the diameter of the stone should be less than or equal to 2cm; 3. Aged 18 to 75 years old male and female; 4. Sign the informed consent form and voluntarily participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Uncorrected systemic bleeding disorders; 2. Those with previous history of severe heart disease or pulmonary insufficiency who cannot tolerate surgery; 3. pelvic kidney or severe renal ptosis; 4. Imaging suggests urethral stricture or ureteral stricture, which cannot be treated in the mirror; 5. For subjects with lesions of stones, the stone diameter is greater than 2 cm; 6. Severe hip deformity, unable to meet the surgical position requirements; 7. History of blood system disease, taking drugs that interfere with blood coagulation, or abnormal blood coagulation; 8. Those who have suffered from mental illness in the past; 9. Those with cognitive impairment; 10. pregnant or lactating women; 11. Those who have participated in other clinical trials within 3 months; 12. The investigator believes that other circumstances are not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
Rate of qualified products;

Secondary

MeasureTime frame
Stone removal rate;

Countries

China

Contacts

Public ContactNiu Yuanjie

The Second Hospital of Tianjin Medical University

yuanjie_niu1@163.com+86 13821827881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026