End Stage Renal Disease (ESRD)NCT07436559
AVF Stenosis by Electronic Stethoscope
An observational study of End Stage Renal Disease (ESRD), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Detection and Prediction of the stenosis of arteriovenous fistula in hemodialysis patients by an electronic stethoscope
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Mar 2023to 30 Sep 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End stage renal disease patients received hemodialysis for more than 3 months
Who may be able to join
- Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent
Who cannot join
- Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Yunlin Branch
Douliu, Taiwan, 640
About this study
Official title: Detection and Prediction of the Stenosis of Arteriovenous Fistula in Hemodialysis Patients by an Electronic Stethoscope
The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals.
- Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope?
This study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Detection and Prediction of the stenosis of arteriovenous fistula in hemodialysis patients by an electronic stethoscope
- Keywords
- Electronic stethostope, Arteriovenous fistula, Regression analysis, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection and Prediction of the stenosis of arteriovenous fistula in hemodialysis patients by an electronic stethoscopeDevice
The detection of the arteriovenous fistula must rely on the assistance of professionals by palpation or a conventional stethoscope. This study will investigate the detection and prediction of arteriovenous fistula stenosis in hemodialysis patients by an electronic stethoscope.
What is being measured
The primary outcome is the main question the study is designed to answer.
AVF stenosis
Clinical stenosis: Diagnosed by attending nephrologist based on physical examination abnormalities (high-pitched bruit, pulsatile flow, diminished thrill) - Confirmed by Doppler ultrasound showing >50% diameter reduction - Intervention: Percutaneous transluminal angioplasty (PTA)
Measured: From enrollment to the end of study at 3 months
Secondary outcomes (1)
Abnormal AVF sound threshold
Defined using statistical analysis of post-PTA normal sounds
Measured: From enrollment to the end of study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start17 Mar 2023
- Primary completion16 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436559
- Sponsor's protocol ID
- 202302099RINA
- Other IDs
- AVF stenosis detection
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Prediction of the Stenosis of Arteriovenous Fistula in Hemodialysis Patients by an Electronic Stethoscope
- ClinicalTrials.gov ID
- NCT07436559
- Acronym / sponsor ID
- 202302099RINA
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Electronic stethostope, Arteriovenous fistula, Regression analysis, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Feb 2026 (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 prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals.
- Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope?
This study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End stage renal disease patients received hemodialysis for more than 3 months
Key inclusion criteria (1 listed)
- Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent
Key exclusion criteria (1 listed)
- Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent
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 |
|---|---|---|
| Detection and Prediction of the stenosis of arteriovenous fistula in hemodialysis patients by an electronic stethoscopeThe detection of the arteriovenous fistula must rely on the assistance of professionals by palpation or a conventional stethoscope. This study will investigate the detection and prediction of arteriovenous fistula stenosis in hemodialysis patients by an electronic stethoscope. | Device | – |
Primary outcome
AVF stenosis
Time frame: From enrollment to the end of study at 3 months
Clinical stenosis: Diagnosed by attending nephrologist based on physical examination abnormalities (high-pitched bruit, pulsatile flow, diminished thrill) - Confirmed by Doppler ultrasound showing >50% diameter reduction - Intervention: Percutaneous transluminal angioplasty (PTA)
1 secondary outcome
Abnormal AVF sound threshold
Time frame: From enrollment to the end of study at 3 months
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 4 Aug 2026.
- 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 End Stage Renal Disease (ESRD), run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 Aug 2026. 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 Taiwan. 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?
AVF stenosis (time frame: From enrollment to the end of study at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.