Renal Insufficiency, ChronicNCT06600750
Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination
An observational study of Renal Insufficiency, Chronic and Arteriovenous Fistula, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Artificial Intelligence (AI)
- What is being tested?
- Arteriovenous fistula
- Type of treatment
- Surgery or procedure
- How many people
- 494 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022
Who may be able to join
- patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022
Who cannot join
- Patients who did not have follow-up data available
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Artificial Intelligence (AI), Machine Learning
- Being tested
- Arteriovenous fistula
- Keywords
- Preoperative Ultrasound Mapping, Radiocephalic Arteriovenous Fistula, Renal Dialysis, Artificial intelligence, Machine Learning, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous fistulaProcedure or surgery
Patients who underwent Radiocephalic arteriovenous fistula surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease | Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease Receives: Procedure: Arteriovenous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ara Cho, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600750
- Sponsor's protocol ID
- S2020-3118-0001
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25736517Vascular 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.
PubMed 16813991Perera 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.
PubMed 14727162
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination
- ClinicalTrials.gov ID
- NCT06600750
- Acronym / sponsor ID
- S2020-3118-0001
- Conditions
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Artificial Intelligence (AI), Machine Learning
- Keywords
- Preoperative Ultrasound Mapping, Radiocephalic Arteriovenous Fistula, Renal Dialysis, Artificial intelligence, Machine Learning, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease | – | Procedure: Arteriovenous fistulaPatients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022
Key inclusion criteria (1 listed)
- patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022
Key exclusion criteria (1 listed)
- Patients who did not have follow-up data available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriovenous fistulaPatients who underwent Radiocephalic arteriovenous fistula surgery | Procedure or surgery | Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease |
Primary outcome
Maturation of the fistula
Time frame: 90 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Results publication: PubMed 25736517Georgiadis 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.
- Results publication: PubMed 16813991Vascular 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.
- Results publication: PubMed 14727162Perera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic and Arteriovenous Fistula, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation of the fistula (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06600750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.