DialysisNCT07891741
Study of 3D Ultrasound for Support of Hemodialysis Cannulation
A study testing EchoMap in people with Dialysis, run by Sonavex, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dialysis
- What is being tested?
- EchoMap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2026to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
CN Clinical Research
Greenville, South Carolina, 29605
- Recruiting
Hartford Dialysis
Hartford, Connecticut, 06112
DaVita Clinical Research, 413-386-5360, jean.dowd@davita.com
- Recruiting
Greater Waterbury Dialysis
Middlebury, Connecticut, 06762
DaVita Clinical Research, 413-386-5360, jean.dowd@davita.com
About this study
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.
- Conditions
- Dialysis
- Being tested
- EchoMap, Standard of Care Cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoMapDevice
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 CannulationOther
Dialysis technicians will use the rope ladder or area cannulation technique (not button hole) to avoid repeat cannulation in the same location.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: SOC First | Active comparator | This group will be cannulated using Standard of Care techniques only for the first three dialysis sessions, and the 7th, 8th, and 9th dialysis session. The first group will be cannulated using EchoMap in support of standard techniques for the 4th through 6th dialysis session, and again for the 10th through 12th session. Receives: Device: EchoMap; Other: Standard of Care Cannulation |
| Stage 1: EchoMap First | Experimental | This group will be cannulated using EchoMap in support of Standard of Care for the 1st through 3rd dialysis session, and the 7th through 9th dialysis session. The second group will be cannulated using Standard of Care techniques for the 4th through 6th dialysis session, and again for the 10th through 12th session. Receives: Device: EchoMap; Other: Standard of Care Cannulation |
| Stage 2: SOC | Active comparator | Subjects will undergo standard cannulation practices only. Receives: Other: Standard of Care Cannulation |
| Stage 2: EchoMap | Experimental | Subjects assigned to the EchoMap arm, for 12 dialysis sessions they will be cannulated using EchoMap in support of Standard of Care only. For Receives: Device: EchoMap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Successful Cannulation Sessions
Number of dialysis sessions with successfully cannulated for dialysis treatment of the fistula
Measured: Up to 24 weeks
Stage 1: Number of Sticks
The number of times a needle penetrated the skin during a cannulation attempt
Measured: Up to 24 weeks
Stage 1: Number of Needle Advancements
How many times a needle was advanced, regardless of how many needles were used
Measured: Up to 24 weeks
Stage 1: Number of Cannulation Related Infiltrations
Perforation of the side or deep wall of the fistula resulting in pain, swelling, hematoma formation, or temporary or permanent loss of blood flow through the needle.
Measured: Up to 24 weeks
Stage 1: Presence and Severity of Infiltration Related Hematoma
Grade 1 - Stable hematoma and patient is able to initiate hemodialysis via the fistula as intended.
Grade 2 - Stable hematoma, but patient is unable to initiate dialysis via the fistula as intended, or requires the use of a catheter or an intervention to use the fistula for hemodialysis, for one or more dialysis treatments.
Grade 3 - Major complication where the vessel has ruptured. Hematoma is unstable and requires treatment to save fistula or fistula is lost.
Measured: Up to 24 weeks
Stage 1: Missed Dialysis Session
Number of missed dialysis due to a cannulation failure or injury
Measured: Up to 24 weeks
Stage 1: CVC Used
Whether a catheter was used for one or two needles due to an inability to cannulate or cannulation failure
Measured: Up to 24 weeks
Stage 1: CVC Placement
Whether a catheter was placed for dialysis due to cannulation failure or injury
Measured: Up to 24 weeks
Stage 1: Blood Stream Infections
Number of bloodstream infections
Measured: Up to 24 weeks
Stage 1: Freedom from device related adverse events
Number of device related adverse events
Measured: Up to 24 weeks
Stage 1: Cannulator Experience
Cannulator experience questionnaire to be completed before the first subject is treated and after the last subject has finished Stage 1
Measured: Up to 24 weeks
Stage 2: Patient Experience
Patient experience questionnaire to be completed before the end of Stage 2.
Measured: Up to 24 weeks
Stage 2: Freedom from device related adverse events
Number of device related adverse events
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start7 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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. Stage 1 will occur over 12 dialysis sessions and will utilize a concurrent control, where each subject will serve as their own control. To provide a concurrent control, patients will be cannulated with a different technique every three dialysis sessions. Patients will be randomized into two even groups. In Stage 2, all of the subjects will be followed for an additional 12 dialysis sessions. Subjects will be randomized 1:1. Half of the subjects will always be cannulated with EchoMap in support of Standard of Care and half will be cannulated with Standard of Care only.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonavex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891741
- Sponsor's protocol ID
- EG-FS-2025
- Other IDs
- 2R44DK131644
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No