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Study of 3D Ultrasound for Support of Hemodialysis Cannulation

Sonavex, Inc. · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT07891741

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
3
Study start
May 7, 2026
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: EchoMap; Standard of Care Cannulation

Conditions: Dialysis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Hartford Dialysis

    Hartford, CT 06112

    Site contact: DaVita Clinical Research · 413-386-5360 · jean.dowd@davita.com

  • Greater Waterbury Dialysis

    Middlebury, CT 06762

    Site contact: DaVita Clinical Research · 413-386-5360 · jean.dowd@davita.com

  • CN Clinical Research

    Greenville, SC 29605

Study contacts (from the official record)

  • R Del Negro · 4438622024 · rdelnegro@sonavex.com
Study of 3D Ultrasound for Support of Hemodialysis Cannulation (NCT07891741) | Bored Studies