What this study is
Simplified from ClinicalTrials.govTesting a 3D ultrasound device (EchoMap) to learn whether it is safe and works as an aid to usual methods of placing needles in an AV fistula, the blood vessel connection used for hemodialysis, in adults ages 18 to 85 who get hemodialysis through an AV fistula.
Read the original summary from ClinicalTrials.gov
This study is a prospective, single arm, multi-center two-stage feasibility study designed to evaluate the safety and effectiveness of the use of the EchoMap device to assist in traditional methods of AV fistula cannulation.
What's being tested
- EchoMap
Intervention · DEVICE
EchoMap is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current Standard of Care cannulation methods.
- Standard of Care Cannulation
Intervention · OTHER
Dialysis technicians will use the rope ladder or area cannulation technique (not button hole) to avoid repeat cannulation in the same location.
Study details
- Sponsor
- Sonavex, Inc.
- Conditions
- Dialysis
- Enrolling
- 20 people
- Starts
- 2026-05-07
- Est. completion
- 2026-12-30
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age > 18 years but < 85 years of age at the time of informed consent
- Subjects who have received an upper extremity autologous arteriovenous fistula, which has been cleared for at least 1-needle cannulation
- Subjects have a fistula with a history of miscannulation or requires an expert cannulator or have a new fistula that has not previously been cannulated
- Subject is able to sign informed consent and able to participate in all testing associated with this clinical investigation
You can't join if
- Age <18 years old
- Subject unable to sign informed consent.
- Subject is breastfeeding, pregnant, or plans to become pregnant
- Prisoner or Subject from vulnerable populations as defined in 45 CFR 46.
- Subjects that do not have a clinically mature upper extremity AV fistula that is cleared for at least 1-needle cannulation
- Subjects that do not have a fistula with a history of miscannulation or requires an expert cannulator or do not have a new fistula that has not previously been cannulated
- Subjects that are cannulated through a buttonhole technique
- Subjects with a history of poor compliance with the dialysis protocol
- Subjects who have suffered an access related injury or underwent access related intervention in the last 2 weeks
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for 2 of 3 open sites
- DaVita Clinical Research · Contact413-386-5360jean.dowd@davita.com
Hartford Dialysis
Hartford, Connecticut, United States
RecruitingGreater Waterbury Dialysis
Middlebury, Connecticut, United States
RecruitingCN Clinical Research
Greenville, South Carolina, United States
Recruiting
Study team
Sponsor
Sonavex, Inc.
Study ID EG-FS-2025
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.