The Accuracy of Ultrasonic Viscoelastic Imaging in Evalua... | NCT06961162

Studies
The Accuracy of Ultrasonic Viscoelastic Imaging in Evaluating the Severity of Chronic Kidney Diseases

NCT06961162

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

May 7, 2025Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Chronic Kidney Disease(CKD)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2023Actual

Primary Completion Date

Mar 25, 2024Actual

Completion Date

Jun 3, 2024Actual

First Submitted Date

Apr 29, 2025

First Submission Date that Met QC Criteria

May 6, 2025

First Posted Date

May 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2025

Last Update Posted Date

May 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the role of ultrasonic viscoelastic parameters in the assessing the severity of chronic kidney disease. The main question it aims to answer is:

The accuracy of ultrasonic viscoelastic parameters in evaluating the degree of renal fibrosis and inflammation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Measure	Description	Time Frame
renal fibrosis degree		one week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) fulfilled the diagnostic criteria for CKD (disease course > 3months); (2) underwent renal biopsy, (3) a prior 2D-SWE evaluation preceding the renal biopsy, and (4) obtained informed written consent.

Exclusion Criteria:

(1) the presence of multiple renal cysts, calculi, hydronephrosis, or masses that could potentially interfere with the analysis conducted through 2D-SWE: (2) unsuccessful 2D-SWE measurements ;(3) biopsy specimens deemed inadequate due to insufficient length (less than 10 mm) or fewer than 10 glomeruli, and (4) incomplete clinical data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CKD patients who underwent renal biopsy at Peking University Third Hospital based on clinical requirements

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ligang Cui, Dr	Department of Ultrasound, Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ultrasound, Peking University Third Hospital		Beijing	Beiing	100191	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41618226	Derived	Zeng L, Lu M, Lee JM, Niu H, Fu Y, Yao Y, Tang W, Jiang J, Ma J, Cui L. The accuracy of ultrasound viscoelastic imaging in evaluating renal fibrosis and interstitial inflammation of chronic kidney disease. BMC Nephrol. 2026 Jan 30;27(1):140. doi: 10.1186/s12882-026-04762-y.

ID	Term
D051436	Renal Insufficiency, Chronic
D005355	Fibrosis
D007249	Inflammation

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases