Recruiting

EchoMap

Sponsor:

Sonavex, Inc.

Code:

NCT07891741

Conditions

Dialysis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EchoMap

Standard of Care Cannulation

Study Details

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

Study ID

NCT07891741

Start date

May 7, 2026

Status verified date

Oct, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Stage 1: SOC First

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.

experimental: Stage 1: EchoMap First

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.

active comparator: Stage 2: SOC

Subjects will undergo standard cannulation practices only.

experimental: Stage 2: EchoMap

Subjects assigned to the EchoMap arm, for 12 dialysis sessions they will be cannulated using EchoMap in support of Standard of Care only. For

Interventions

EchoMap

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

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

Primary outcome measure

  • Stage 1: Successful Cannulation Sessions [ Time Frame: Up to 24 weeks ]
  • Stage 1: Number of Sticks [ Time Frame: Up to 24 weeks ]
  • Stage 1: Number of Needle Advancements [ Time Frame: Up to 24 weeks ]
  • Stage 1: Number of Cannulation Related Infiltrations [ Time Frame: Up to 24 weeks ]
  • Stage 1: Presence and Severity of Infiltration Related Hematoma [ Time Frame: Up to 24 weeks ]
  • Stage 1: Missed Dialysis Session [ Time Frame: Up to 24 weeks ]
  • Stage 1: CVC Used [ Time Frame: Up to 24 weeks ]
  • Stage 1: CVC Placement [ Time Frame: Up to 24 weeks ]
  • Stage 1: Blood Stream Infections [ Time Frame: Up to 24 weeks ]
  • Stage 1: Freedom from device related adverse events [ Time Frame: Up to 24 weeks ]
  • Stage 1: Cannulator Experience [ Time Frame: Up to 24 weeks ]
  • Stage 2: Patient Experience [ Time Frame: Up to 24 weeks ]
  • Stage 2: Freedom from device related adverse events [ Time Frame: Up to 24 weeks ]

Central Contacts and Locations

Central contacts

R Del Negro

4438622024rdelnegro@sonavex.com

Locations

Hartford Dialysis

Recruiting

Hartford, Connecticut, United States, 06112

Contacts

DaVita Clinical Research

413-386-5360jean.dowd@davita.com

Greater Waterbury Dialysis

Recruiting

Middlebury, Connecticut, United States, 06762

Contacts

DaVita Clinical Research

413-386-5360jean.dowd@davita.com

CN Clinical Research

Recruiting

Greenville, South Carolina, United States, 29605

More Information

Sponsor

Sonavex, Inc.

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sonavex, Inc. on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.