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Acceptability of a novel "DialyAssist" device for stabilising needles in the arm when people have haemodialysis

Acceptability of a novel "DialyAssist" device for stabilising needles in arteriovenous fistulae of people receiving haemodialysis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000277448
Enrollment
40
Registered
2025-04-10
Start date
2025-06-09
Completion date
2025-11-24
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to evaluate the acceptability of the DialyAssist device to patients receiving haemodialysis and further to evaluate whether it improves the dialysis experience. After informed consent, people receiving haemodialysis will complete assessment of the specific effect having an arteriovenous fistula has on their quality of life using the VASQoL instrument. Those who agree to trying the new device will use the device for six sessions and repeat the VASQoL instrument. Scores on item 2 (“In the last week I am satisfied with how my line / fistula/ graft feels during dialysis.”) will be compared before and after using the device.

Interventions

Use of the novel "DialyAssist" device to stabilise the needles in the arteriovenous fistula or graft, and also stabilise the arm during a haemodialysis session.. The intervention will be applied by the dialysis nursing staff, who will monitor its use for the duration of the dialysis session (usually 4-5 hours) and remove it at the end. The intervention period will involve use of the device for six consecutive haemodialysis sessions. The DialyAssist device is a plastic device designed to sec

Use of the novel "DialyAssist" device to stabilise the needles in the arteriovenous fistula or graft, and also stabilise the arm during a haemodialysis session.. The intervention will be applied by the dialysis nursing staff, who will monitor its use for the duration of the dialysis session (usually 4-5 hours) and remove it at the end. The intervention period will involve use of the device for six consecutive haemodialysis sessions. The DialyAssist device is a plastic device designed to secure the fistula arm, needles and tubing during dialysis that has been developed by a person with lived experience of hemodialysis.

Sponsors

Eastern Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients receiving haemodialysis via an AVF (or graft) Provision of informed consent

Exclusion criteria

Use of a dialysis catheter Undergoing haemodialysis at home

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026