Corbotics' pivotal trial: Revolutionizing TTEs Through Robotics.

There is a worldwide shortage of transthoracic echocardiography (TTE)
sonographers. A recent study has quantified these shortages for the United
States [3]. Furthermore, recent data from the UK suggest that 40% of hospitals
failed to meet the standard of >=90% of patients presenting with acute heart
failure undergoing echocardiography [4]. Lastly, the Bureau of Labour
Statistics states a projected percent change in employment of medical
sonographers and cardiovascular technologists and technicians from 2022 to 2032
of 10% (while the average is 3%), resulting in a need for a growth of 14,200
employees by 2032 [5].

Performing TTEs is repetitive and physically strenuous work, performed by
skilled professionals. A study in 2009 has shown that 90% of Diagnostic Medical
Sonographers suffer from work-related muscoskeletal disorders (an increase of
9% since the last large-scale survey in 1997) [6]. Across all demographics,
shoulder pain is most common, with older and more experienced sonographers
having more finger, hand, and wrist pain than other groups. Pain continues to
be related to pressure applied to the transducer, abduction of the arm, and
twisting of the neck and trunk. Robots are ideally suited to support jobs
characterized by repetitive, safe and precise movements, and found their way to
surgery settings. Their introduction to the field of echocardiography could be
part of the solution to the shortage of sonographers and even increase the
capacity for routine TTE examinations. Our hypothesis is that robots, in
combination with artificial intelligence (AI), are capable of performing high
quality, standard protocol TTEs, that produce clinically usable images without
the need for a sonographer and can be deployed in clinical practice to expand
TTE capacity.

Echocardiography is the main diagnostic imaging tool for the diagnosis,
follow-up or ruling out of a broad spectrum of heart disease. Since the
majority of patients visiting the outpatient cardiology department have an
indication for a TTE, a large capacity is required (both in terms of cardiac
ultrasound machines and qualified sonographers).
The WHO reports that in 2016, there was an estimated global needs-based
shortage of health care workers in general, of about 17.4 million [6].
For the Netherlands, data regarding the increasing demand for echocardiograms
are not available. However, in the hospitals where the current study will be
performed, finding enough qualified sonographers to fulfil the demand is
difficult. The American Ultrasound Technician Centre also speaks about a
growing demand for cardiovascular sonographers [8].

In the near future, the demand for TTEs will increase further. One of the main
indications to perform a TTE is the suspicion of heart failure, and up to 2019,
there has been an increase in hospital admittance due to heart failure
(hartstichting.nl). It is expected that with an ageing population, the
prevalence of heart failure will increase, and concomitantly, the demand for
TTEs. This was already seen in the UK, where an increase in the prevalence of
cardiovascular disease and increase in prevalence of heart failure was
reported, which led to an annual growth of approximately 3% in the number of
echocardiograms performed [10].

The shortage of cardiac sonographers results in long waiting times and
subsequent undesirable treatment delays. To overcome the shortage in cardiac
sonographers and the problems related to it, a product like the BedBasedEcho
(BBE) would be very useful. Less (qualified) personnel would be needed to guide
the patient through a TTE.
Delays in diagnostics can result in preventable cardiovascular events, and
additional capacity can reduce such delays.

Corbotics B.V. is the developer of the BBE. The goal of Corbotics B.V. is to
robotically perform a TTE fully autonomously. The robot is mounted under a
specially designed bed providing access to the thorax by a specific opening.
Using the opening, the robot can access the anterior and anterolateral side of
the thorax of the patient (lying in a prone position or on the left side). The
ultrasound system and ECG system are off-the-shelf certified ME Equipment.
Corbotics B.V. develops the mechanical steering of the probe and the embedded
software.
Artificial intelligence (AI) is used to develop view-finding algorithms. This
AI is developed to find the precise locations on the thorax for obtaining the
standard echo views (parasternal long axis, parasternal short axis, apical
views, and subcostal views including measurements). For now, the suprasternal
view is not (yet) included, since it is impossible to perform these with the
BBE in a prone position. The indication for the suprasternal view is limited to
certain specific questions (i.e., severe aortic valve insufficiency and/or
coarctation).

The goal of the study is to evaluate the quality of TTEs produced autonomously
by the BBE. The primary endpoint will be the percentage of TTEs obtained
autonomously by the BBE that are usable in clinical practice, compared to the
percentage of clinically usable TTEs obtained manually using the BBE, as
reviewed by ten EACVI (European Association of Cardiovascular Imaging)
certified cardiologists.

This will be the first study to examine the feasibility of cardiac
echocardiography through robotics with fully independent control. Previously,
studies have been performed using a remotely controlled robot for
echocardiography, however, this was mainly to timely diagnose patients in
remote areas at a distance, and thus with use of a remote operator [3].

Study type and setting
This is a multicentre, single blinded, non-randomized feasibility study carried
out in six Dutch clinical centres; the LUMC (Leiden University Medical Centre,
academic hospital), UMC Utrecht, HagaZiekenhuis, OLVG, Isala and Catharina (the
latter four are cardiac referral centres in The Hague, Amsterdam, Zwolle and
Eindhoven, respectively; hospitals that perform triage for a wide array of
their cardiac interventions, based on ultrasound in daily practice).

During the study, at most two centres will concurrently be collecting data for
the study. Two BBE*s are available for data collection, which will be placed at
different centres throughout the study based on the centre*s availability of
resources.

During the study, no additional space/room in the study centre is needed. The
BBE can be placed in the same room as existing TTE modalities that are used for
conventional TTEs outside of this study. The BBE can be used as bed for these
conventional TTEs if required.

Study phases
It was decided to perform the study in two phases in order to be able to use
the study results of the first phase (including participant satisfaction) to
further develop the BBE and optimize its performance before commencing phase 2.
This means that the study may be temporarily halted between phase 1 and phase 2
if the performance of the BBE is insufficient or if BBE performance can be
further improved by the findings of phase 1.

Study duration
The total duration of the study is highly dependent on the availability of
participants and sonographers. A minimum of fifteen (15) participants per week
is targeted from each study centre for the duration that a BBE is installed at
their location. If a centre is not able to meet this target, the sponsor might
decide to relocate the BBE to another centre that is able to meet this target
at that point in time. With this target, the first phase will effectively take
4 weeks (100 participants, 2 BBE*s operating in parallel at two different
centres). Phase 2 will take 9 weeks (250 participants). Taking into account the
time needed to install the BBE, train personnel, analyse the data and write a
clinical trial report, the expected duration of the study is nine (9) months.
The study will start on 01-07-2024, and the study will end on 01-04-2025.

Each participant will first undergo a TTE performed manually by a sonographer
using the manual probe of the BBE, and then a TTE performed autonomously by the
BBE. The data resulting from the manual TTE will be used as a comparator to
assess the quality of the data resulting from the autonomous TTE. These TTEs
will be performed on the same day.

Use of the BBE, if working and used according to the intentional use, entails
minimal risk for the participant. Risks are further minimized by building
algorithms in the software, that for example, prevent the BBE from applying too
much force on the thorax (minimizing the experience of pain or discomfort).
Also, heat development from the robot arm (not the probe itself) is limited;
the arm can only reach a temperature of 44.6°C. The arm is unable to come in
contact with the participant by itself, but the participant might touch the arm
intentionally. A temperature of 48°C is able to produce skin burns, but only
after 17 minutes of contact to the source [1] [2]. The BBE stays below that
temperature.

Participants may be injured climbing on and off the bed, just like in the case
of a standard TTE made by a sonographer, but risks are minimized using trained
personnel to guide the participant through the examination.