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Safety and useability of a novel robot-assisted echocardiographic examination

Safety and useability of a novel robot-assisted echocardiographic examination in adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000979550
Enrollment
30
Registered
2024-08-12
Start date
2024-10-21
Completion date
2024-11-19
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

This pilot study aims to investigate the safety and useability of robotically assisted echocardiographic examinations (echo). The technology is aimed to be deployed in any location (including regional and remote) and may be controlled remotely. Should this study be successful it will allow access of essential standard of care to cardiac patients in remote and rural areas.

Interventions

Alternative format of non-invasive diagnostic procedure - cardiac ultrasound a) Robot-assisted echocardiographic examination b) Procedure - Utilisation of existing clinically used cardiac ultrasound systems where system probe is held by robotic arm. c) Delivery - Sonographer utilises a gamepad to control the robotic arm system to acquire images. Any ultrasound system is permitted, and a specific vendor is utilised based on the discretion of the hospital. Sonographers will undergo a minimum of

Alternative format of non-invasive diagnostic procedure - cardiac ultrasound a) Robot-assisted echocardiographic examination b) Procedure - Utilisation of existing clinically used cardiac ultrasound systems where system probe is held by robotic arm. c) Delivery - Sonographer utilises a gamepad to control the robotic arm system to acquire images. Any ultrasound system is permitted, and a specific vendor is utilised based on the discretion of the hospital. Sonographers will undergo a minimum of 15 hrs of virtual (software-based only) and hand-on simulator training, prior to human echocardiogram scanning. Standard operation manuals are provided to ensure correct and standardised use of the system. All participants of the study will have previously undergone (prior to consent) a clinically required standard of care manual echocardiographic examination. The robotically assisted echocardiographic examination will be conducted within 72 hours of the manual scan.

Sponsors

RMI Oceania Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

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

Inclusion criteria

1. Male or female aged 18 years or older 2. Inpatient or outpatient who has already received a routine (manual) echocardiogram that has been clinically reported. 3. Is willing to participate. 4. Provides written informed consent.

Exclusion criteria

1. Is pregnant. 2. Has poor patient mobility or is acutely symptomatic.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026