- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00702559
Design the Home Care Platform for the Monitoring of A Hemodialysis Arteriovenous Graft by Intelligent Physiological Signal
Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous lumen is gradually dilated and the wall thickened, producing an access that can be routinely needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients will experience access stenosis, dysfunction, and even thrombosis, which are the most common complications of a hemodialysis access.
Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use traditional stethoscope as a convenient method to evaluate the patency and function of a hemodialysis access before, during, and after each session of dialysis. The acoustic signal of an access is always affected by environmental noises, non-specific in nature, and the sensitivity to detect stenosis is very low.
With the development and use of electronic stethoscope, the proprietary ambient noise acoustically cancels out an average of 75% of distracting room noise, greatly enhancing overall utility. However, the output acoustic signals are still apprehended by the ear, which is the main source of bias and errors of detection.
Our study purpose is to apply the signal processing technology to transfer the acoustic signals into simple visual signals that provide an easy way to read. It can be used by a professional medical staff, a non-professional person responsible for taking care, or even the patient himself, disability or not, as an early screening detector of stenosis or dysfunction of a hemodialysis access.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chih-Yang Chan, MD, PhD
- Phone Number: 886-8966-7000
- Email: chanchihyang@mail.femh.org.tw
Study Locations
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Taipei, Taiwan
- Recruiting
- Far Eastern Memorial Hospital
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Contact:
- Chih-Yang Chan, MD, PhD
- Phone Number: 886-8966-7000
- Email: chanchihyang@mail.femh.org.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- prosthetic grafts with clinical signs of dysfunctions or malfunctions and were referred for angiographic evaluations.
Exclusion Criteria:
- autologous arteriovenous accesses or known thrombosed accesses.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FEMH-96040
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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