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出境医 / 临床实验 / Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Study Description
Brief Summary:
This study evaluates the role of an implanted ultrasonic fiducial marker and automated Duplex for evaluating the maturation of peripheral arteriovenous fistulae created for the purpose of establishing long term hemodialysis access in patients with end stage renal disease.
| Condition or disease | Intervention/treatment |
|---|---|
| Arteriovenous Fistula Arteriovenous Graft Hemodialysis Complication | Device: Implantation of ultrasonic fiduciary |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients |
| Actual Study Start Date : | December 2, 2019 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | March 1, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Arteriovenous fistula maturation rate [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- The volume of blood per unit time through the fistula anastomosis as measured by ultrasound [ Time Frame: 12 weeks ]
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||||
| First Posted Date | July 12, 2019 | ||||||
| Last Update Posted Date | January 12, 2021 | ||||||
| Actual Study Start Date | December 2, 2019 | ||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Arteriovenous fistula maturation rate [ Time Frame: 12 weeks ] | ||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
The volume of blood per unit time through the fistula anastomosis as measured by ultrasound [ Time Frame: 12 weeks ] | ||||||
| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients | ||||||
| Official Title | Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients | ||||||
| Brief Summary | This study evaluates the role of an implanted ultrasonic fiducial marker and automated Duplex for evaluating the maturation of peripheral arteriovenous fistulae created for the purpose of establishing long term hemodialysis access in patients with end stage renal disease. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Adult patients undergoing arteriovenous fistula creation for hemodialysis access | ||||||
| Condition |
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| Intervention | Device: Implantation of ultrasonic fiduciary
Implantation of a small ultrasonic apparent device at the time of arteriovenous fistula creation.
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Suspended | ||||||
| Estimated Enrollment |
100 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | March 1, 2022 | ||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04017910 | ||||||
| Other Study ID Numbers | 2019-02 2R44HL147423-04 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Sonavex, Inc. | ||||||
| Study Sponsor | Sonavex, Inc. | ||||||
| Collaborators | National Heart, Lung, and Blood Institute (NHLBI) | ||||||
| Investigators |
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| PRS Account | Sonavex, Inc. | ||||||
| Verification Date | January 2021 | ||||||
