Study of 3D Ultrasound for Support of Hemodialysis Cannulation

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Stage 1: Successful Cannulation Sessions — Up to 24 weeks
  Number of dialysis sessions with successfully cannulated for dialysis treatment of the fistula
• Stage 1: Number of Sticks — Up to 24 weeks
  The number of times a needle penetrated the skin during a cannulation attempt
• Stage 1: Number of Needle Advancements — Up to 24 weeks
  How many times a needle was advanced, regardless of how many needles were used
• Stage 1: Number of Cannulation Related Infiltrations — Up to 24 weeks
  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.
• Stage 1: Presence and Severity of Infiltration Related Hematoma — Up to 24 weeks
  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.
• Stage 1: Missed Dialysis Session — Up to 24 weeks
  Number of missed dialysis due to a cannulation failure or injury
• Stage 1: CVC Used — Up to 24 weeks
  Whether a catheter was used for one or two needles due to an inability to cannulate or cannulation failure
• Stage 1: CVC Placement — Up to 24 weeks
  Whether a catheter was placed for dialysis due to cannulation failure or injury
• Stage 1: Blood Stream Infections — Up to 24 weeks
  Number of bloodstream infections
• Stage 1: Freedom from device related adverse events — Up to 24 weeks
  Number of device related adverse events
• Stage 1: Cannulator Experience — Up to 24 weeks
  Cannulator experience questionnaire to be completed before the first subject is treated and after the last subject has finished Stage 1. Answer can range from Strongly Disagree (1) to Strongly Agree (7)
• Stage 2: Patient Experience — Up to 24 weeks
  Patient experience questionnaire to be completed before the end of Stage 2. Using AF-VAQ, Answer can range from Strongly Disagree (1) to Strongly Agree (7)
• Stage 2: Freedom from device related adverse events — Up to 24 weeks
  Number of device related adverse events

Trial sites (3)

More Sonavex, Inc. trials in the USA

Other trials for the same condition