Study of 3D Ultrasound for Support of Hemodialysis Cannulation

NCT07891741 | Recruiting DMC FDA Device

• 2 other identifiers: EG-FS-20252R44DK131644
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dialysis

Outcome Measures

Primary Outcomes (13)

• Stage 1: Successful Cannulation Sessions

  Number of dialysis sessions with successfully cannulated for dialysis treatment of the fistula

  Up to 24 weeks

• Stage 1: Number of Sticks

  The number of times a needle penetrated the skin during a cannulation attempt

  Up to 24 weeks

• Stage 1: Number of Needle Advancements

  How many times a needle was advanced, regardless of how many needles were used

  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.

  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.

  Up to 24 weeks

• Stage 1: Missed Dialysis Session

  Number of missed dialysis due to a cannulation failure or injury

  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

  Up to 24 weeks

• Stage 1: CVC Placement

  Whether a catheter was placed for dialysis due to cannulation failure or injury

  Up to 24 weeks

• Stage 1: Blood Stream Infections

  Number of bloodstream infections

  Up to 24 weeks

• Stage 1: Freedom from device related adverse events

  Number of device related adverse events

  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

  Up to 24 weeks

• Stage 2: Patient Experience

  Patient experience questionnaire to be completed before the end of Stage 2.

  Up to 24 weeks

• Stage 2: Freedom from device related adverse events

  Number of device related adverse events

  Up to 24 weeks

Study Arms (4)

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.

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.

Device: EchoMap; Other: Standard of Care Cannulation

Stage 2: SOC

ACTIVE COMPARATOR

Subjects will undergo standard cannulation practices only.

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

Device: EchoMap

Interventions

EchoMap 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.

Stage 1: EchoMap First; Stage 1: SOC First; Stage 2: EchoMap

Standard of Care Cannulation OTHER

Dialysis technicians will use the rope ladder or area cannulation technique (not button hole) to avoid repeat cannulation in the same location.

Stage 1: EchoMap First; Stage 1: SOC First; Stage 2: SOC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Sonavex, Inc.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Hartford Dialysis

Hartford, Connecticut, 06112, United States

RECRUITING

Greater Waterbury Dialysis

Middlebury, Connecticut, 06762, United States

RECRUITING

CN Clinical Research

Greenville, South Carolina, 29605, United States

RECRUITING

Central Study Contacts

R Del Negro

CONTACT

4438622024; rdelnegro@sonavex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)