Patients undergoing dialysis for end stage renal disease. Urological and Genital Diseases
Conditions
Interventions
Each participant will have the study device used once during a single dialysis session. The device assists the dialysis nurse or technician in inserting one of the dialysis needles by identifying the
Sponsors
X9, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant, non-breastfeeding females = 18 years of age 2. Presence of an upper extremity arteriovenous fistula (AVF) access site in the forearm or upper arm 3. AVF is actively used for dialysis treatment 4. AVF diameter is between 8 mm and 12mm, confirmed by ultrasound 5. AVF is =6 mm below the surface of the skin, confirmed by ultrasound 6. Able to understand and complete a pain questionnaire 7. Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Arteriovenous graft (AVG) is actively used for dialysis treatment. 2. Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF access site 3. Presence of a condition or impediment that may interfere with ultrasound imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of procedures in which the dialysis needle is successfully inserted into the AVF within three attempts, as confirmed by blood flashback during one cannulation procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of serious adverse events (SAEs) related to the investigational device during one cannulation procedure. | — |
Countries
Uzbekistan
Contacts
Public ContactRachel Walsh
Outcome results
None listed