Arteriovenous Fistula Flow MonitoringNCT05531825
Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
An observational study of Arteriovenous Fistula Flow Monitoring and Early Detection of Complications of Arteriovenous Fistula, run by Ai Peng at 1 site in China.
Trial summary
Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arteriovenous Fistula Flow Monitoring, Early Detection of Complications of Arteriovenous Fistula, Voiceprint
- What is being tested?
- A device for detecting arteriovenous fistula vascular function
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with end-stage renal disease undergoing or planning regular hemodialysis with autologous arteriovenous fistulas
Who may be able to join
- Age 18-75.
- Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis.
- Sign the informed consent.
Who cannot join
- Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness.
- Other circumstances deemed inappropriate by the researcher
- Quit midway
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200272
Ai Peng, MD,PhD, Shanghai, pengai@tongji.edu.cn
About this study
Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.
Read the detailed description
Arteriovenous fistula is the lifeline of maintenance hemodialysis patients. At present, there is a lack of a simple wearable real-time evaluation technology and device for arteriovenous fistula, which can help doctors find and deal with the complications of arteriovenous fistula timely and accurately. This study proposes an innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels, so that the use time of arteriovenous fistula can be prolonged and the survival rate of dialysis patients can also be improved.
- Conditions
- Arteriovenous Fistula Flow Monitoring, Early Detection of Complications of Arteriovenous Fistula, Voiceprint
- Being tested
- A device for detecting arteriovenous fistula vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A device for detecting arteriovenous fistula vascular functionDevice
An innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels
| Study group | Role | What they receive |
|---|---|---|
| Normal control group | Patients with no disease in the main organs, with well-developed body shape, and with good physiological functions, physical activity abilities and labor abilities. Receives: Device: A device for detecting arteriovenous fistula vascular function | |
| Newly established arteriovenous fistula group | Chronic kidney disease stage 5 (CKD5) non-dialysis patients planning to undergo internal arteriovenous fistula surgery. Receives: Device: A device for detecting arteriovenous fistula vascular function | |
| reconstructed arteriovenous fistula group | Patients with maintenance hemodialysis who need to reconstruct the internal arteriovenous fistula on account of dissatisfaction with blood flow. Receives: Device: A device for detecting arteriovenous fistula vascular function | |
| Long-term maintenance hemodialysis group | Patients undergoing hemodialysis with long-term fixed internal arteriovenous fistula. Receives: Device: A device for detecting arteriovenous fistula vascular function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula Flow MonitoringStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ai Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ai Peng, MD,PhD, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531825
- Sponsor's protocol ID
- SHSY-IEC-5.0/22K54/P01
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
- ClinicalTrials.gov ID
- NCT05531825
- Acronym / sponsor ID
- SHSY-IEC-5.0/22K54/P01
- Conditions
- Arteriovenous Fistula Flow Monitoring, Early Detection of Complications of Arteriovenous Fistula, Voiceprint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ai PengUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Sep 2022 (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.
Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.
Detailed description
Arteriovenous fistula is the lifeline of maintenance hemodialysis patients. At present, there is a lack of a simple wearable real-time evaluation technology and device for arteriovenous fistula, which can help doctors find and deal with the complications of arteriovenous fistula timely and accurately. This study proposes an innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels, so that the use time of arteriovenous fistula can be prolonged and the survival rate of dialysis patients can also be improved.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal control group | – | Device: A device for detecting arteriovenous fistula vascular functionPatients with no disease in the main organs, with well-developed body shape, and with good physiological functions, physical activity abilities and labor abilities. |
| Newly established arteriovenous fistula group | – | Device: A device for detecting arteriovenous fistula vascular functionChronic kidney disease stage 5 (CKD5) non-dialysis patients planning to undergo internal arteriovenous fistula surgery. |
| reconstructed arteriovenous fistula group | – | Device: A device for detecting arteriovenous fistula vascular functionPatients with maintenance hemodialysis who need to reconstruct the internal arteriovenous fistula on account of dissatisfaction with blood flow. |
| Long-term maintenance hemodialysis group | – | Device: A device for detecting arteriovenous fistula vascular functionPatients undergoing hemodialysis with long-term fixed internal arteriovenous fistula. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage renal disease undergoing or planning regular hemodialysis with autologous arteriovenous fistulas
Key inclusion criteria (3 listed)
- Age 18-75.
- Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis.
- Sign the informed consent.
Key exclusion criteria (3 listed)
- Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness.
- Other circumstances deemed inappropriate by the researcher
- Quit midway
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 |
|---|---|---|
| A device for detecting arteriovenous fistula vascular functionAn innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels | Device | Long-term maintenance hemodialysis group, Newly established arteriovenous fistula group, Normal control group, reconstructed arteriovenous fistula group |
Primary outcome
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
Time frame: 2 month
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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.
Ai Peng, MD,PhD study director
Shanghai 10th People's Hospital
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 Arteriovenous Fistula Flow Monitoring and Early Detection of Complications of Arteriovenous Fistula, run by Ai Peng at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ai Peng, MD,PhD (86-21-66302524, pengai@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula (time frame: 2 month). 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 8 Sep 2022.