Ultrasound-guided needle placement for dialysis access
| ISRCTN | ISRCTN22547122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22547122 |
| Protocol serial number | CP-00001 |
| Sponsor | X9, Inc. |
| Funder | X9, Inc. |
- Submission date
- 10/11/2025
- Registration date
- 12/11/2025
- Last edited
- 12/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study is testing a new device that helps dialysis staff place the first dialysis needle. The device shows the location of your access (fistula) and gives real-time guidance to help line up the needle and enter the vessel. The study will check if using the device is feasible and safe, with the main goal of seeing whether one needle can be placed successfully.
Who can participate?
Patients (not pregnant or breastfeeding) aged 18 and older who are currently undergoing dialysis.
What does the study involve?
Participation will be very brief—only about one to three minutes during the regular dialysis session. The device will be used by the dialysis nurse or technician to help guide the placement of one needle. It will not change the treatment or extend the dialysis time, and it fits naturally into the usual care routine. Participation is complete once the dialysis session is finished.
What are the possible benefits and risks of participating?
Benefits: Participants may not receive direct medical benefits. What is learnt could help improve future tools for safer, more accurate needle placement and potentially reduce complications over time.
Risks: The risks are the same as routine cannulation, such as pain, bruising, bleeding, infiltration, or missed sticks.
Where is the study run from?
The study is run from Uzbekistan.
When is the study starting and how long is it expected to run for?
The study is expected to run for one month in October 2025.
Who is funding the study?
X9, Inc.
Who is the main contact?
Rachel Walsh at X9, inc., Rwalsh@x9med.com
Contact information
Public, Scientific
10 Research Pkwy
Wallingford
06492
United States of America
| Phone | +1 (650) 472-0307 |
|---|---|
| rwalsh@x9med.com |
Principal investigator
Talabalar street, 52
Tashkent
100095
Uzbekistan
| Phone | +998 90 943 4836 |
|---|---|
| siseptember8@gmail.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Device feasibility | |
| Study type | Participant information sheet | |
| Scientific title | Ultrasound-guided power-assisted needle insertion for vascular access | |
| Study acronym | ACCESS-1 | |
| Study objectives | The primary objective of the study is to evaluate successful insertion of one dialysis needle into the AVF for cannulation. | |
| Ethics approval(s) |
Approved 16/10/2025, Ethics Committee affiliated with the Ministry of Health of Uzbekistan (Tashkent, 100015, Aybek str., 45, Tashkent, 100015, Uzbekistan; +(99871) 256-37-38, 256-14-89; info@minzdrav.uz), ref: 10/1-2202 | |
| Health condition(s) or problem(s) studied | Patients undergoing dialysis for end stage renal disease. | |
| Intervention | 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 location of the vascular access (fistula) and providing ultrasound and AI-based localization guidance to deliver accurate needle placement for dialysis cannulation. The duration of exposure to the device is expected to be brief, lasting approximately one to three minutes. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Ultrasound-Guided, Power-Assisted Needle Insertion | |
| Primary outcome measure(s) |
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. | |
| Key secondary outcome measure(s) |
Absence of serious adverse events (SAEs) related to the investigational device during one cannulation procedure. | |
| Completion date | 26/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Total final enrolment | 7 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/10/2025 |
| Date of final enrolment | 26/10/2025 |
Locations
Countries of recruitment
- Uzbekistan
Study participating centre
Yangiyul
100095
Uzbekistan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/11/2025: Study's existence confirmed by the Ministry of Health of Republic of Uzbekistan Ethical Committee.
