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A Multicenter Observational Study on Methodological Optimization and Clinical Validation of Ultra Resolution Microscopy Imaging for Renal Transplants

A Multicenter Observational Study on Methodological Optimization and Clinical Validation of Ultra Resolution Microscopy Imaging for Renal Transplants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113893
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Transplanted Kidney Diseases

Interventions

Index test:Ultrasound ultra resolution microscopy imaging. A total of 150 patients were randomly assigned in a 1:1:1:1:1:1 ratio to six groups: convex array (S1-8C) probe with volumes of 0.8 ml, 1.0 m
linear array (U5-15L) probe with volumes of 0.6 ml, 0.8 ml, and 1.0 ml (one group each).

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. First-time recipients of allogeneic renal transplants, including living or deceased donors; 2. Age >=18 years; 3. End-to-side anastomosis of the donor renal artery to the external or internal iliac artery.

Exclusion criteria

Exclusion criteria: 1. Combined multi-organ transplantation; 2. Second or subsequent renal transplantation, dual kidney transplantation (mostly recipients of pediatric donor kidneys); 3. History of malignancy; 4. Severe failure of other organs (e.g., heart, liver, lungs, etc.); 5. Contraindications related to ultrasound contrast agents; 6. Lactation or pregnancy; 7. Hydronephrosis of the transplanted kidney >=2 cm, moderate to large peritransplant fluid collection [maximum depth of fluid >=2 cm, including complications such as urinary tract obstruction, urinoma (urine leakage, first 2 weeks post-operation), lymphocele (4-8 weeks post-operation), perirenal infection, etc.; 8. Inability to cooperate, unsatisfactory image acquisition, or missing clinical data.

Design outcomes

Primary

MeasureTime frame
Microvascular imaging-related indicators (URM density, URM Curvature, URM Complexity Level, Density Fit, Density Analysis, URM Location Velocity, Velocity Analysis, Perfusion Index, Density Velocity Analysis);Glomerulus Number;Predictive performance;

Secondary

MeasureTime frame
Grayscale ultrasound (size, echo intensity, renal cortical thickness);Spectral Doppler ultrasound (PSV, EDV, RI, and PI);

Countries

China

Contacts

Public ContactZhou Jiaojiao

West China Hospital, Sichuan University

zhoujiaojiao@wchscu.cn+86 185 8183 0427

Outcome results

None listed

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