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NCT06190717 · ClinicalTrials.gov registry record · NA
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
A NA study of Diabetes and End Stage Renal Disease, sponsored by Sonavex.
- Recruiting
- Registry status
- NA
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT06190717: Recruiting NA study of Diabetes and End Stage Renal Disease, sponsored by Sonavex.
NCT06190717 is a NA study of Diabetes and End Stage Renal Disease that is actively recruiting participants, run by Sonavex. The registered enrollment target is 304 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06190717, a NA study of Diabetes and End Stage Renal Disease, is actively recruiting participants, sponsored by Sonavex.
- RECRUITING
- Registry status
- NA
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
Primary Outcome
Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.
Conditions Studied
Interventions
- DEVICE EchoMark/EchoSure
- PROCEDURE Standard of Care
Study Locations (20)
Arizona
- Southwest Kidney Institute - Phoenix
- AKDHC Medical Research Services - Phoenix
- AKDHC Center Tucson - Tucson
South Carolina
- Prisma Health - Greenville
- Medical University of South Carolina Health Orangeburg - Orangeburg
Tennessee
- Galen Medical Group - Chattanooga
- Fresenius Vascular Care Memphis MSO - Memphis
Texas
- Baylor Scott & White Heart and Vascular Hospital - Dallas
- Aqua Research Institute Llc - Houston
Virginia
- Physicians Care of Virginia - Roanoke
- Sentara Health - Virginia Beach
Alabama
- Trinity Research Group - Dothan
Florida
- Orlando Health Heart and Vascular Institute - Orlando
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2024-02-21 |
| Est. Completion | 2026-02-01 |
| Phase | NA |
What NCT06190717 shows while recruiting
NCT06190717 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which EchoMark/EchoSure is the first listed.
NCT06190717 names 20 study sites across 14 states, led by Arizona, South Carolina, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06190717 about?
NCT06190717 is a clinical study titled "Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial". This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
What is the current status of trial NCT06190717?
This trial is currently recruiting. It is a NA study. The enrollment target is 304 participants. The study started on 2024-02-21. Estimated completion is 2026-02-01.
What conditions does trial NCT06190717 study?
This clinical trial studies the following conditions: Diabetes, End Stage Renal Disease.
What interventions are being tested in trial NCT06190717?
The interventions under investigation include: EchoMark/EchoSure (DEVICE), Standard of Care (PROCEDURE).
Who is sponsoring clinical trial NCT06190717?
This trial is sponsored by Sonavex, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06190717 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06190717's enrollment target sits among peer trials
304 110th of 338 higher than 229 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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