NCT06600750

Brief Summary

The goal of this observational study is to assess the efficacy of AI-driven models in analyzing comprehensive ultrasonographic variables across multiple forearm locations to predict successful AVF maturation. The main question it aims to answer is: Can AI-driven models analyzing comprehensive ultrasonographic variables accurately predict the successful maturation of arteriovenous fistulas (AVFs)? Participants who underwent radiocephalic arteriovenous fistula (AVF) creation had their preoperative ultrasonographic data analyzed using AI-driven models to predict successful AVF maturation over a four-year retrospective period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

September 16, 2024

Last Update Submit

September 24, 2024

Conditions

Renal Insufficiency, ChronicArteriovenous FistulaArtificial Intelligence (AI)Machine Learning

Keywords

Preoperative Ultrasound MappingRadiocephalic Arteriovenous FistulaRenal DialysisArtificial intelligenceMachine LearningChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Maturation of the fistula

    Fistula maturation was defined as an arteriovenous fistula that matures and is usable for dialysis with two-needle cannulation for hemodialysis for at least 90 days without the need for endovascular or surgical interventions.

    90 days

Study Arms (1)

Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease

Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease

Procedure: Arteriovenous fistula

Interventions

Arteriovenous fistulaPROCEDURE

Patients who underwent Radiocephalic arteriovenous fistula surgery

Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022

You may qualify if:

  • patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022

You may not qualify if:

  • Patients who did not have follow-up data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Publications (3)

  • Georgiadis GS, Charalampidis DG, Argyriou C, Georgakarakos EI, Lazarides MK. The Necessity for Routine Pre-operative Ultrasound Mapping Before Arteriovenous Fistula Creation: A Meta-analysis. Eur J Vasc Endovasc Surg. 2015 May;49(5):600-5. doi: 10.1016/j.ejvs.2015.01.012. Epub 2015 Feb 27.

    PMID: 25736517BACKGROUND

  • Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.

    PMID: 16813991BACKGROUND

  • Perera GB, Mueller MP, Kubaska SM, Wilson SE, Lawrence PF, Fujitani RM. Superiority of autogenous arteriovenous hemodialysis access: maintenance of function with fewer secondary interventions. Ann Vasc Surg. 2004 Jan;18(1):66-73. doi: 10.1007/s10016-003-0094-y. Epub 2004 Jan 20.

    PMID: 14727162BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicArteriovenous Fistula

Interventions

Arteriovenous Shunt, Surgical

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)