Evaluation of Advanced US Tools in Assessing Allograft Complications

February 6, 2023 updated by: Imperial College London

The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications

This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will focus on monitoring renal after transplantation using all US advanced technology.

Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.

Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.

Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.

Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.

Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients having /had kindey transplant

Description

INCLUSION CRITERIA

  • Patients ≥ 18 years.
  • Tx patients.
  • Gender.

EXCLUSION CRITERIA

  • Prisoners.
  • Patients < 18 years.
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplanted kidney
No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards
Device: 3D imaging

The study will focus on the accuracy of ultrasound technology in assessing renal transplants.

The entire assessment should not take more than 25 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistive Index (RI).
Time Frame: 12 weeks
An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.
12 weeks
Peak systolic velocity (cm/s).
Time Frame: 12 weeks
Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1
12 weeks
Peak systolic velocity ratio (PSVR).
Time Frame: 12 weeks
High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric stenosis.
Time Frame: 12 weeks
Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
12 weeks
3D GSM.
Time Frame: 12 weeks
Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2022

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 848 -20HH6053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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