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.
| Condition(s) | Diabetes, End Stage Renal Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent. * Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures. * Subject is willing and capable of complying with all required follow-up visits. * Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance. * Subject has an estimated life expectancy \> 18 months. * Subject is ambulatory (cane or walker are acceptable). * CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Lead sponsor | Sonavex, Inc. |
| Locations | Dothan, Alabama, United States; Phoenix, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Orlando, Florida, United States; Chicago, Illinois, United States (+15 more sites) |
| Start date | 2024-02-21 |
| NCT ID | NCT06190717 |
| Official listing | https://clinicaltrials.gov/study/NCT06190717 |