Evaluation of Seismocardiography (SCG) as a Tool for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
Conditions: Oesophageal Cancer, Oesophageal Adenocarcinoma, Prehabilitation, Oesophagectomy, Neoadjuvant Chemotherapy
Sponsor: Guy's and St Thomas' NHS Foundation Trust

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
1 
 
Title 
Evaluation of Seismofit® as a tool for assessing fitness and 
predicting outcomes in Oesophageal cancer surgery 
SEISMIC study (SEISMocardiography In oesophageal 
Cancer) 
Authors 
Kesav Aditya, Mr Andrew Davies
Protocol Reference: 
 
Version Number & Date:  
Version: 1.0 
Date: 08/04/2025 
Effective Date: 
 
 
IRAS Number:  
 
342434 
Superseded Version 
Number & Date  
(If applicable)  
N/A  
Sponsor 
Guy’s & St Thomas’ NHSFT
Chief Investigator 
Mr Andrew Davies BSc, MBChB, MSc, MD, FRCS
Site Principal Investigators 
Prof Tim Underwood / Prof Denny Levett (Southampton)
Mr Pritam Singh (Guildford) Mr Rob Walker (Guildford) 
Mr Sach Kumar (RMH), Dr Don Milliken (RMH) 
Keywords 
Seismocardiography, SCG, Cardiorespiratory ﬁtness, 
Cardiopulmonary Exercise testing, CPET, surgery, 
Oesophageal cancer, complications 
 
 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
2 
Contents 
Trial Summary in Lay English .................................................................................................. 4 
Background ........................................................................................................................... 4 
Study Setting ...................................................................................................................... 5 
Description of the Device Being Studied .............................................................................. 5 
Rationale ........................................................................................................................... 6 
Research Question/Aim(s) ............................................................................................... 6 
Study Outcomes ................................................................................................................ 6 
Primary outcome ............................................................................................................ 6 
Secondary Outcomes ..................................................................................................... 6 
Study Design and Methods of data collection and analysis. ..................................................... 7 
Seismoﬁt® Measurement .................................................................................................... 8 
Allocation of Treatment ....................................................................................................... 8 
Blinding .............................................................................................................................. 8 
Study Summary Flow Chart ................................................................................................. 8 
Data Collection and Handling ............................................................................................. 9 
Data Flow Diagram ........................................................................................................... 11 
Patient Follow-Up ............................................................................................................. 11 
Source Data and Documents ............................................................................................ 12 
Sampling and Recruitment ................................................................................................... 12 
Inclusion Criteria .............................................................................................................. 12 
Exclusion Criteria ............................................................................................................. 12 
Withdrawal Criteria ........................................................................................................... 12 
Consent ........................................................................................................................... 12 
Sampling .......................................................................................................................... 13 
Size of Sample Rationale ............................................................................................... 13 
Statistics .......................................................................................................................... 13 
Recruitment ..................................................................................................................... 14 
Screening ..................................................................................................................... 14 
Ethical, Regulatory Considerations and Trial Registration....................................................... 14 
Research Ethics Committee and Other Regulatory Review and Reports .............................. 14 
Good Clinical Practice ...................................................................................................... 15 
Protocol Compliance and Deviations ................................................................................ 15 
Data Protection and Patient Conﬁdentiality ....................................................................... 15 
Study Organisation, Trial Monitoring and Management Strategy ............................................. 16 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
3 
Study Management Responsibilities .................................................................................. 16 
Study Early Termination / Suspension Criteria .................................................................... 17 
End of Trial ....................................................................................................................... 17 
Trial Monitoring ................................................................................................................. 18 
Insurance and Liability ...................................................................................................... 18 
Contact with General Practitioner (GP) .............................................................................. 18 
Clinical Study Reporting Policy .......................................................................................... 19 
Reporting and Publication ................................................................................................. 19 
Conﬂict of Interest ............................................................................................................ 19 
Safety Reporting................................................................................................................... 19 
Adverse Event (AE) ............................................................................................................ 19 
Serious Adverse Event (SAE) ............................................................................................. 20 
Investigator Responsibilities ............................................................................................. 20 
Assessment of Severity ..................................................................................................... 20 
Assessment of Seriousness .............................................................................................. 20 
Assessment of Causality................................................................................................... 20 
Assessment of Expectedness............................................................................................ 21 
Reporting of Adverse Events .............................................................................................. 21 
Reportable events ......................................................................................................... 21 
Reporting Timelines .......................................................................................................... 21 
Funding ............................................................................................................................... 22 
APPENDIX 1 ......................................................................................................................... 23 
APPENDIX 2 ......................................................................................................................... 24 
References .......................................................................................................................... 25 
 
 
 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
4 
Trial Summary in Lay English 
Cancer aƯecting the Oesophagus is a common cause of cancer-related deaths around the 
world. Treatment of this involves a combination of chemotherapy and surgery to remove the 
Oesophagus. There are a lot of risks associated with this treatment; therefore, it’s important to 
make sure patients are ﬁt for this pathway and to see which patients will have higher risks 
compared to others. Cardiopulmonary exercise Testing, or CPET for short, is the most detailed 
and accurate test in predicting how ﬁt someone is, and we can use these ﬁtness markers to see 
which patients will have higher treatment-related risks. However, CPET is diƯicult to use 
because it takes a long time, has extra clinic appointments in an already busy treatment 
schedule, is expensive, and requires a trained exercise physiologist to run the test. In this study, 
we are trying to see if a new device smaller than a modern smartphone can be used to give an 
accurate estimate of patient ﬁtness and if this device can also predict treatment-related 
complications. 
Background 
Oesophageal cancer is the 8th most common cause of cancer and the 6th leading cause of 
cancer-related deaths worldwide(West et al., 2016; Liu et al., 2023). Surgery with curative intent 
has been associated with signiﬁcant morbidity and mortality despite recent advancements in 
anaesthesia and surgical techniques(Wu et al., 2014). Good patient selection with optimisation 
of cardiorespiratory ﬁtness (CRF) is essential to improve surgical outcomes(West et al., 2014; 
Ozova et al., 2022). This is particularly important given that most oesophageal cancer patients 
undergo neo-adjuvant treatment (e.g. chemotherapy), which is known to have a signiﬁcant 
adverse eƯect on patient ﬁtness before surgery (mean reduction of 12.1% in VO2Peak) (Jack et 
al., 2014). A lower baseline level of ﬁtness has also been shown to be associated with morbidity 
and mortality in patients undergoing treatment with curative intent (Hennis et al., 2011; West et 
al., 2024). Prehabilitation is now considered the standard of care in oesophageal cancer 
surgery, with societal guidance recently recommending a baseline ﬁtness assessment to tailor 
the intervention as well as a means of monitoring response (Walker et al., 2024). 
Cardiopulmonary Exercise Testing (CPET) is considered the gold standard in measuring the CRF 
of an individual by obtaining the maximal volume of oxygen consumed (VO2Peak) in samples of 
expired gas during a graded eƯort cycle ergometer test (Krogh et al., 2020; Levett et al., 2018a). 
However, CPET is a resource-intensive, costly, time-consuming test (requiring up to 60 minutes) 
and creates a signiﬁcant time burden on patients with already busy treatment schedules. In a 
UK survey of prehabilitation practice, 50% of Upper Gastrointestinal (UGI) units used CPET at 
baseline, with only 80% of these (40% total) using CPET for response assessment (Barman et al. 
2024 in revision for publication Annals RCS Eng). 
Seismoﬁt® is a device that accurately estimates the VO2Peak using machine learning 
algorithms incorporating seismocardiography (SCG) and patient parameters such as height, 
weight, age, and gender. SCG is a process by which vibrations generated by the heart during its 
regular physiological cycles are characterised and mapped for changes in morphology, 
frequency, intensity and character(Sørensen et al., 2018). Key advantages of Seismoﬁt® include 
its inter-test reliability, rapid availability of results (i.e., estimation of ﬁtness in under 3 minutes 
in an outpatient setting), and accurate estimation of ﬁtness in a resting patient (Hansen et al., 
2023a). The accuracy of Seismoﬁt® in comparison to CPET-measured CRF has previously been 
demonstrated with a Mean Absolute Percentage Error (MAPE) of 12.3% in healthy adult 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
5 
populations(Hansen et al., 2023b). However, there is minimal data on cancer patients, and no 
studies have correlated VO2Peak generated by Seismoﬁt® to clinical outcomes. 
Given the potential beneﬁts of Seismoﬁt® over CPET, this study will investigate its validity in a 
clinical setting across four major Oesophageal cancer resection centres (Guy’s and St Thomas 
NHS Foundation Trust (GSTT), University Hospitals Southampton (UHS), Royal Marsden NHS 
Foundation Trust (RM) and Royal Surrey NHS Foundation Trust (RS).  
This will be the ﬁrst study to evaluate the use of Seismoﬁt® in a large volume of oesophageal 
cancer patients. With correlation to clinical outcomes, this study will serve as the basis for 
future research into the use of Seismoﬁt® in a clinical setting. 
Study Setting 
The study will be conducted between the four hospitals, which are centralised regional 
Oesophageal cancer resection centres in the United Kingdom.  
 
Guys and St Thomas (GSTT) 
 
Royal Marsden NHS Foundation Trust (RMH) 
 
Royal Surrey NHS Foundation Trust (RS) 
 
University Hospital Southampton (UHS) 
Recruitment of patients will occur at the ﬁrst point of contact of patients to the cancer surgery 
clinic. The total duration of the study recruitment will be 24 months, with an expected start date 
in May 2025, following completion of the ethical approval process. The enrolment period will be 
completed once 164 patients with complete records are identiﬁed for analysis. 
An initiation visit for each enrolled site will be conducted, and a documented report on the site 
leads, including their signatures, functions, and authorizations within this study, will be 
generated. This report will outline the agreements between the sponsor and the investigation 
site, as well as the responsibilities of each party at the clinical investigation site. 
Site teams will also be provided with the following: 
 
Protocol 
 
Investigators Brochure (IB) for the Seismoﬁt® Devices(Conﬁdentiality, 2011) 
 
Device Instructions for use Manual (Ventriject, n.d.) 
 
Research Electronic Data Capture (REDCap) Access for the research team 
 
Patient consent form templates 
 
Instructions for use on the Seismoﬁt® devices 
 
A copy of the agreements in place. 
Description of the Device Being Studied 
Seismoﬁt® is a 3 x 5 x 1.5 cm Class I medical device manufactured by Ventriject, which utilizes 
SCG principles and machine learning to estimate an individual's ﬁtness.  It is aƯixed to a 
patient’s sternum with an adhesive patch. It measures the amplitude and timing of vibrations on 
the chest using accelerometers. The device then averages the data collected over 45 seconds 
to create the SCG. From the SCG, several maxima and minima (ﬁducial points) are identiﬁed, 
which correlate to the opening and closing of the mitral and aortic valves.  

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
6 
Features of the SCG, including the timing, frequency, amplitude, and variability of these points, 
are then incorporated into an algorithm that also considers patient height, weight, age, and sex 
to calculate the VO2 peak. 
Data is transmitted via Bluetooth to an allocated smartphone. The entire process, including 
data acquisition and transmission, takes around three minutes, displaying a VO2 peak estimate 
on the smartphone app. 
Rationale 
This pioneering study will mark the ﬁrst evaluation of Seismoﬁt® estimated VO2peak in a clinical 
setting. Oesophageal cancer patients, a group typically considered ﬁt for surgery, will be the 
focus. They are generally homogeneous and capable of withstanding the physiological strain of 
NAC and single lung ventilation during the cancer resection operation.  
Seismoﬁt®, as demonstrated in previous studies, is accurate and carries no risk when used on 
healthy patients. It provides results in under 3 minutes and is user-friendly, unlike CPET, which 
takes over 30 minutes per assessment and necessitates the presence of a trained physiologist. 
Therefore, in a clinical setting, we aim to assess the utility of Seismoﬁt® in the Oesophageal 
cancer patient population and explore the association between Seismoﬁt® estimated VO2Peak 
and clinical outcomes. 
Research Question/Aim(s) 
The primary hypothesis is that Seismoﬁt®-estimated VO2peak and trends in VO2Peak measured 
throughout the treatment period would be associated with clinically meaningful outcomes, 
such as the postoperative rate of pneumonia, overall complications (as deﬁned by the Clavien-
Dindo classiﬁcation), and hospital length of stay (LOS).   
Secondary hypotheses are that Seismoﬁt®-estimated VO2peak will be associated with CPET 
with a <15% mean absolute percentage error (MAPE) and will identify the same patients in the 
lowest quartile of ﬁtness as CPET. Furthermore, Seismoﬁt® estimated VO2peak will correlate 
with other clinical parameters such as chemotherapy completion, chemotherapy 
complications and tolerability, anastomotic leak and ITU LOS.  
Study Outcomes  
Primary outcome 
1. Seismoﬁt® estimated VO2Peak and trends in estimated VO2Peak through the treatment 
period are correlated with: 
a. Rate of pneumonia as deﬁned by the Esophageal Complications Consensus 
Group criteria (ECCG).  
b. Overall rate of complications as deﬁned by the Clavien-Dindo classiﬁcation 
c. Hospital LOS 
Secondary Outcomes 
1. Seismoﬁt® estimated VO2Peak reading accuracy compared to “gold standard” CPET 
measured VO2Peak. 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
7 
2. Accuracy of Seismoﬁt® compared to CPET in identifying patients in the lower quartile of 
ﬁtness. 
3. Other clinical outcomes 
a. Chemotherapy compliance & tolerability – completion of all prescribed cycles, 
dose reductions, and complications as deﬁned by the Common Terminology 
Criteria for Adverse Events (CTCAE) version 5 published by the National Institute 
for Health, National Cancer Institute. 
b. ITU length of stay (and re-admission) 
c. Anastomotic leak rates 
4. Assessment of clinical outcomes related to CPET-measured ﬁtness (VO2Peak) 
a. Rate of pneumonia as deﬁned by the ECCG 
b. Overall rate of complications as deﬁned by the Clavien-Dindo classiﬁcation 
c. Hospital length of stay. 
Study Design and Methods of data collection and analysis. 
This post-market observational cohort clinical study will assess the association of Seismoﬁt® 
estimated ﬁtness to clinical outcomes. All patients presenting to the pre-operative assessment 
clinic will be screened and oƯered enrolment if they meet the inclusion criteria deﬁned in this 
protocol's sampling and recruitment section. 
CPET is routinely performed at RMH, RS and UHS; however, it is not performed as part of routine 
pre-operative assessment at GSTT. Therefore, CPET-measured pre-treatment ﬁtness (and post-
treatment where performed) will be undertaken only in centres where it is the current standard 
of care. This minimises changes to the current diagnostic and staging protocols at each centre. 
Seismoﬁt® estimations of ﬁtness will be the only added assessment in the patient’s treatment 
pathway during this study. Clinicians will be blinded to the results of the Seismoﬁt® VO2peak 
readings, i.e. these will not contribute in any way to decision-making.   
Morbidity outcomes will be measured throughout the study period with overall complications 
standardised by the Clavien-Dindo classiﬁcation and speciﬁc complications as outlined by the 
Esophagectomy Complications Consensus Group (ECCG). These will include: 
 
Pulmonary – Pneumonia, atelectasis due to mucous plugging requiring bronchoscopy, 
respiratory failure requiring re-intubation, acute respiratory distress syndrome, 
tracheobronchial injury. 
 
Cardiac – Perioperative myocardial infarction, development of cardiac arrhythmia 
requiring interventions, pericarditis requiring treatment. 
 
Gastrointestinal – Anastomotic leakage, conduit necrosis/failure, ileus, small bowel 
obstruction, C.DiƯicile infection, gastrointestinal bleeding requiring intervention, 
pancreatitis and liver dysfunction. 
 
Renal – Development of AKI/Renal failure and stage 
 
Thromboembolic – DVT, PE, stroke 
 
Multi-organ dysfunction 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
8 
Seismoﬁt® Measurement  
Patients will be asked to conﬁrm whether they have participated in any strenuous exercise 10 
minutes before the Seismoﬁt® reading. If they indicate yes, Seismoﬁt® readings will be delayed 
until 10 minutes have passed. 
The device will be placed on the lower part of the patient’s sternum with an adhesive pad. The 
patient’s height, age, weight and sex will be entered into the smartphone app. The patient will be 
requested to lie still in the supine position whilst the device takes SCG measurements and gives 
an estimate of the VO2Peak within three minutes. 
Seismoﬁt® readings will be taken at various stages of a patients’ clinical course, outlined below:  
1. Baseline (initial surgical clinic once eligibility / planned treatment established) 
2. Post NAC (within three weeks of completing NAC) 
3. Pre-surgery (within three weeks before surgery) 
4. Post Operative Day (POD) 1, 3, and 7 (or at discharge if sooner) 
5. First clinic visits after discharge from hospital (within three weeks of discharge). 
The algorithm used to estimate VO2Peak is the proprietary intellectual property of Ventriject. 
The most up-to-date version of the algorithm at the time of the study's commencement will be 
used in all estimations from commencement to trial completion.  
However, the estimation algorithm is assumed to improve with the data pool generated in this 
trial. Post-hoc repeat ﬁtness estimates will be generated from all anonymised patients if an 
updated version of the algorithm becomes available through trial. 
Training Requirements for the Use of Seismoﬁt®  
Training for the Seismoﬁt® devices at each research site will be conducted during the initiation 
visit.  
The use of the device will be demonstrated to all research staƯ involved in the study. The 
documented report at the end of the initiation visit will outline the completion of all relevant 
training. 
Allocation of Treatment 
All patients included in the trial will have Seismoﬁt® at the described time points. Subject 
participation in the study will commence with enrolment in the trial and conclude at the time of 
the ﬁnal Seismoﬁt® reading (post-operative clinic), approximately 6 months later. 
Blinding 
Seismoﬁt® measurements will be performed by research staƯ trained in the use of the device, 
who will not be involved in the clinical decision-making process for patient management. This 
will ensure that the patient's clinical management is not biased by the measurements 
generated by the Seismoﬁt® device. 
Study Summary Flow Chart 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
9 
 
*CPET measurements and results are taken where they are part of the patient's standardised 
pathways.  
Data Collection and Handling 
The following data points will be collected from the enrolled patients: 
 
Patient Demographics required in the current version of the estimation algorithm 
o Age 
o Sex 
o Height 
o Weight – This must be repeated at each point the Seismoﬁt® readings are taken.  
o BMI- This must be repeated at each point the Seismoﬁt® readings are taken.  
 
American Society of Anaesthesiologists (ASA) Grade at surgery 
 
Performance status 
 
Charlson Co-morbidity index 
 
Existing Co-morbidities of patients  
Patients identified through 
diagnosis of Oesophago-Gastric 
Cancer at MDT
Exclusion Criteria
Age <18
Pregnancy
Patients scheduled for Primary 
Oesophagectomy/Oesophago-
Gastrectomy
NACRT
Squamous CElls Carcinoma
Patients unable to consent.
Patients approaced in Clinic on First 
Contact and Enrolled into Study
BaselineCPET *+ SCG Assessment 
NAC
SCG assessment<3 weeks post 
NAC
Surgery
SCG Assessment3 weeks prior to 
Surgical Resection
SCG Readings 
POD1
SCG Readings 
POD3
SCG Readings 
POD7/or at
discharge 
SCG Reading at First 
Post Operative Follow-
upClinical Review
Patients lost to Follow up/Dropouts

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
10 
o Cardiac – The presence of any Arrhythmia, cardio-selective anti-arrhythmic 
medications use, Hypertension, and ejection fraction on baseline 
echocardiography reports will be recorded. 
o Respiratory – The presence of asthma / COPD / Interstitial Lung Diseases will be 
recorded. 
o Renal – The presence of any pre-existing chronic kidney diseases and Baseline 
eGFR at the time of enrolment will be recorded. 
o Endocrine – The presence of any hormonal supplements taken, or any pre-
existing conditions being treated will be recorded. 
o GastroIntestinal – Previous operative history, any known diagnosis of 
inﬂammatory bowel diseases or other known diagnoses at baseline will be 
recorded. 
 
Smoking status 
 
Medications  
o Use of Diuretics - Class of Diuretics (Generic name) and dose 
o Use of Anti-Hypertensives –  Class of Anti-Hypertensive (Generic name) and 
dose 
o Use of any Anti-Arrhythmic Medication – Class of Antiarrhythmic (Generic 
name) and Dose 
 
Cancer Type 
 
Tumour ypTNM Staging 
 
Details on any NAC received (cycles) 
 
Complications during NAC - Chemotherapy compliance & tolerability:  
o Completion of all prescribed cycles  
o Dose reductions 
o Complications as deﬁned by the Common Terminology Criteria for Adverse 
Events (CTCAE) version 5 published by the National Institute for Health, National 
Cancer Institute 
 
Seismoﬁt® Estimated VO2Peak 
 
Haemoglobin (Hgb) Values - Most up-to-date Haemoglobin reading at each Seismoﬁt® 
Reading. 
 
CPET Measured Variables – VO2Peak, VO2 AT, Maximum Work (in Watts), Maximum HR 
achieved during the test and Respiratory Equivalent Ratio (RER) 
 
Type of surgery (Open/hybrid / MIO / Robotic AND Ivor Lewis / Transhiatal / Left 
thoracoabdominal / 3 stage) 
 
Record any complications experienced by the patients as standardised by ECCG criteria 
 
Clavien-Dindo complications  
 
ITU LOS / readmission 
 
Hospital LOS 
Research Electronic Data Capture (REDCap) database framework will be established to 
collect data across the four research sites. This method of data retrieval and acquisition was 
selected for the various advantages of: 
 
Data Security – REDCap is a locally hosted database framework at Kings College 
London, with secure web authentication, data logging and Secure Sockets Layer 
Encryption.  

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
11 
 
Ease of distribution and access control – Access to all designated research personnel 
with speciﬁc rights can be granted to users within the research team, creating an added 
layer of data security for compliance with ethical and institutional review. 
 
Data Validation - Customisation of the database with auto-validation can be 
established for data quality rules at the set-up of the database. 
Data Flow Diagram 
 
Patient Follow-Up 
As this device is non-invasive and there are no changes made to the clinical management of the 
patient with all patients receiving standard of care, patients will not be followed up for trial 
purposes only.  
LA:
Legal Avenue
Confidential Data
Non-Confidental Data
GSTT
Guy's and St Thomas' NHS Foundation Trust
RMNHSFT Royal Marsden NHS Foundation Trust
RSNHSFT Royal Surrey NHS Foundation Trust
UHSNHSFTUniversity Hospital Southampton NHS Foundation Trust
GSTT / KCL
Sponsor and 
Controller
RMNHSFT
Identifies and recruits 
participants
RSNHFT
Identifies and 
recruits participants
UHSNHSFT
Identifies and recruits 
participants
GSTT Research Team
Ventriject
MDT Discussion 
Outcomes 
MDT Discussion 
Outcomes 
MDT Discussion 
Outcomes 
GSTT 
Identifies and recruits 
participants
MDT Discussion 
Outcomes 
Hospital ID#,NHS#,DOB, 
Diagnosis, demographics,
Comorbidities, Seismofit 
Cancer Treatments and 
Complications data.
LA: Consent for Disclosure
Instructs sites
Hospital ID#,NHS#,DOB, 
Diagnosis, demographics,
Comorbidities, Seismofit 
Cancer Treatments and 
Complications data.
LA: Consent for Disclosure
Hospital ID#,NHS#,DOB, 
Diagnosis, demographics,
Comorbidities, Seismofit 
Cancer Treatments and 
Complications data.
LA: Consent for Disclosure
Hospital ID#,NHS#,DOB, 
Diagnosis, demographics,
Comorbidities, Seismofit 
Cancer Treatments and 
Complications data.
LA: Consent for Disclosure
Research Team 
Database (REDCap)
CONTROLLER
Pseudonymised Data
LA: Consent for Disclosure
KCL Biostatisticians
Anonymisation and all 
Patient identifiers Stripped, 
Gender,age, comorbidities 
and medications.
LA: Consent for disclosure, 
GSTT non-commercial 
Contract

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
12 
Source Data and Documents 
Source data is "All information in original records and certiﬁed copies of original records or 
clinical ﬁndings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation. Source data are contained in source documents (original 
records or certiﬁed copies)." [ICH E6 section 1.51] 
Source documents are deﬁned as "Original documents, data and records (e.g., hospital 
records, clinical and oƯice charts, laboratory notes, memoranda, subjects' diaries of evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, copies 
or transcriptions certiﬁed after veriﬁcation as being accurate and complete, microﬁches, 
photographic negatives, microﬁlm or magnetic media, x-rays, subject ﬁles, and records kept at 
the pharmacy, at the laboratories, and medico-technical departments involved in the clinical 
trial)." [ICH E6 1.52] 
The electronic patient record will serve as source data for all other data items collected for the 
study.    
Sampling and Recruitment 
Inclusion Criteria 
 
Age >=18 
 
Diagnosis of Oesophageal cancer (T0-4 N0-3 M0, Oesophageal / Gastro-Oesophageal 
Junction (GOJ) type 1-2 adenocarcinoma  
 
Patients being considered for curative treatment (i.e. due to undergo NAC and 
Oesophagectomy / Oesophago-Gastrectomy [open / MIO / hybrid / robotic]) 
 
Patients able to give informed consent  
Exclusion Criteria 
 
Pregnant patients. 
 
Patients under the age of 18. 
 
Patients undergoing primary Oesophagectomy +/- Oesophago-Gastrectomy with no 
neoadjuvant therapy. 
 
Patients undergoing Neoadjuvant chemoradiotherapy. 
 
Patient’s being treated with curative intent for Oesophageal Squamous cell carcinoma 
 
Patients that are deemed not ﬁt or suitable for Oesophagogastric cancer resection as 
part of a Multi-Disciplinary Team meeting decision. 
 
Patients with implanted devices such as pacemakers or cardioverter-deﬁbrillators. 
Withdrawal Criteria 
Patients have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the clinician or at the institution. Withdrawal of 
consent for the study will be documented in the patient’s medical records, and the sponsor 
team will be notiﬁed as soon as possible. A patient may withdraw from future measurements 
but still be included based on measurements already taken, provided they have not withdrawn 
their consent for this as well. 
Consent 

Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
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The Principal Investigator (PI) or an appropriately delegated individual should discuss the trial 
with potentially eligible patients, describing the purpose, alternatives, research objectives, 
potential risks, and follow-up requirements of the study.  
Patients will be provided with a Research Ethics Committee-approved Patient Information Sheet 
(PIS) and given suƯicient time to consider participation in the study and ask any questions. 
Written informed consent will be obtained from all patients who participate in the trial. This will 
be obtained before any data is uploaded to REDCap or Seismoﬁt® measurements are 
performed. 
Sampling  
Size of Sample Rationale 
Sample size calculations were performed with a power of 80% and a signiﬁcance level of 0.05 
(two-sided) for all outcomes. 
The sample size calculations were performed for two primary outcomes: 
1. Rate of Pneumonia Development: To detect a 20% diƯerence between a group of “ﬁt” 
patients and a group of “less ﬁt” patients (deﬁned by the median value) at the 
predetermined power and signiﬁcance, 82 patients will be required in each arm, 
totalling 164. 
2. Hospital LOS: To detect a diƯerence in mean hospital length of stay of 2 days, with a 
standard deviation of 4 days, between a “ﬁt” group compared to a “less ﬁt” group of 
patients at the deﬁned power and signiﬁcance, 64 patients will be required in each arm 
(total 128, satisﬁed by numbers above). 
Sample size calculation was also performed for the secondary outcome: 
1. Association of Seismoﬁt® estimated VO2Peak to gold standard CPET measured 
VO2Peak: To detect a mean diƯerence of 15% (with a SD of 5.62), where the reference 
CPET measured VO2Peak is 23.84ml/kg/min, 22 patients will be required.  
Given the above power calculations, this study aims to recruit 164 patients over 24 months 
across the four research sites. 
Statistics 
Statistical analysis of data will be performed with the support of a dedicated GSTT/KCL medical 
statistician. 
Descriptive statistics will be carried out to summarise patient characteristics. Continuous 
variables will be presented as either mean or median as appropriate. The distribution of 
continuous variables will be investigated using histograms with patient stratiﬁcation based on 
their ﬁtness level in VO2Peak where appropriate. Categorical variables will be presented as a 
frequency (%). 
The Shapiro-Wilk test or an equivalent appropriate statistical model will be used to determine 
whether VO2Peak ﬁtness measurements follow a normal distribution. The diƯerence in the 
means of Seismoﬁt®-estimated VO2Peak in the rate of pneumonia development between a 
cohort of ﬁt and less ﬁt (determined by the median value) patients will form the primary analysis 

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for clinical outcomes. Repeated measures analysis of variance will be used to determine the 
signiﬁcance of changes in Seismoﬁt® estimated VO2Peak measured across the treatment 
period in association with clinical outcomes (i.e. rate of post-operative pneumonia). Box and 
whisker plots will depict the relationship to overall complications as deﬁned by Clavien-Dindo 
classiﬁcation to Seismoﬁt® estimated VO2Peak. Where possible, regression analysis will be 
performed for hospital length of stay to Seismoﬁt® estimated VO2Peak. 
 Association of Seismoﬁt® estimated ﬁtness to gold standard CPET will be determined with a 
MAPE and graphically represented by Bland Altmann plots. Development of chemotherapy and 
operative complications (e.g. anastomotic leaks, respiratory failure, cardiac arrhythmia) will be 
compared using multivariable logistic regression providing odds ratios and 95% conﬁdence 
intervals.  
Recruitment 
Screening 
Prospective patients will be identiﬁed in multidisciplinary team discussions at each research 
site. All patients meeting the inclusion/exclusion criteria will be approached at the ﬁrst clinical 
contact outpatient appointment for study enrollment.  
Ethical, Regulatory Considerations and Trial Registration  
The trial will be run in compliance with the Helsinki Declaration. CPET is a safe investigation, 
widely established in cancer patients, including in those with co-morbidities.(Levett et al., 
2018b) Both CPET and Seismoﬁt® are considered feasible and safe for patients undergoing 
cancer treatment. CPET will not be performed for research purposes only. Seismoﬁt® estimated 
ﬁtness will also not be used to inﬂuence any clinical decisions during this study. 
Seismoﬁt® measurements will be taken during routine clinical visits, thus sparing the patients 
from additional travel to the hospital. Postoperative Seismoﬁt® measurements will be taken at 
the most convenient time for the patient, respecting their dignity and comfort during the post-
operative recovery. 
All data entered into REDCap will follow local and approved ethical standards of patient 
conﬁdentiality. Data validation rules will be established on the REDCap framework per local and 
national protocols, ensuring the highest accuracy and reliability. Before statistical data analysis, 
all variables will be checked for missing, improbable and impossible values to be judged on 
clinical opinion. Missing values will be noted but will not mandate patient exclusion or 
withdrawal of previously collected data provided patient consent has not been withdrawn. 
All software to be used to assist in the analysis of the data will be listed in updated versions of 
this protocol. 
Research Ethics Committee and Other Regulatory Review and Reports  
This study will not commence until written approval/favourable opinion has been obtained from 
the Regulatory Ethics Committee (REC) support through the Integrated Research Application 
System (IRAS).  
 
Integrated Research Application System (IRAS) Ethics Code – ID 342434 – Currently 
in the IRAS registration and approval process. 

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 
GSTT Sponsorship Approval 
 
GSTT Gastrointestinal Medicine and Surgery Study Greenlight Approval 
 
Local GSTT, UHS, RM, RS Registration 
The chief investigator will produce an annual progress report, which will be submitted to the 
REC. This will be submitted within thirty days of the anniversary date of a favourable opinion 
annually until the study is declared ended. 
For any amendment to the study, the research student/designee, in agreement with the sponsor 
and educational supervisor for this project, will submit information to the appropriate body for 
approval.  
The designee will work with sites (R&D departments at NHS sites as well as the study delivery 
team) so they can put the necessary arrangements in place to implement the amendment and 
conﬁrm their support for the study as amended. 
Good Clinical Practice 
The study will be conducted under Good Clinical Practice (GCP) conditions. 
Protocol Compliance and Deviations 
Protocol deviations will be adequately documented on relevant forms and reported to the 
research student/designee and lead sponsors immediately. Frequent deviations from the 
protocol which are found to recur will require immediate action and potentially be classiﬁed as 
a severe breach. 
Data Protection and Patient Conﬁdentiality 
All investigators and study site staƯ must comply with the requirements of the Data Protection 
Act 2018 regarding the collection, storage, processing, and disclosure of personal information. 
They will uphold the act’s core principles. Any requests from participants for access to their 
data held by the chief investigator will be referred to the Data Protection OƯicer at the St 
Thomas’ NHS Foundation Trust.  
Only local research teams will have access to patient-identiﬁable data. The central research 
team at GSTT will have access to pseudonymized data, except for patients recruited locally at 
GSTT. At the time of upload onto REDCap by the local research team, a case number will be 
used to pseudonymise patient data. This case number will be recorded on the consent form and 
may be used if research teams need to trace and link back to the patient.   
Consent forms will be stored in a secure NHS computer system folder at each local research 
site or, where paper forms are used, in a secure locker. In the event paper case reporting forms 
are used, they will also be stored similarly to the paper consent forms in a secure locker. In both 
electronic and physical cases, access to patient-identiﬁable documentation will be limited to 
the local PI/trial manager and other authorised personnel (research students, nursing staƯ, etc.) 
involved in the data set's collection, veriﬁcation or analysis. 
At the end of the study, anonymised data may be sent to Ventriject for improvements in the 
estimation algorithm subject to formal agreement. Data will be anonymised by the creation of a 
unique randomised study number to link the raw Seismocardiography reading generated from 
the device to the below data: 

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 
Patient age at the time of Seismoﬁt reading 
 
Gender 
 
Height and weight,  
 
Previous cardiac co-morbidities 
 
Use of cardio-selective anti-arrhythmic medications, type of medication and dose 
 
Use of diuretic, diuretic type and dose, 
 
Latest cardiac systolic ejection fraction 
 
eGFR value at the time of Seismoﬁt(r) reading 
 
Latest Haemoglobin values at the time of Seismoﬁt(r) reading 
 
Presence of other pulmonary comorbidities 
In the event that data is sent to Ventriject for the purpose of improving the prediction algorithm, 
all data except that listed above will be removed from the data spreadsheet. 
This study utilizes complex algorithms, which are the proprietary intellectual property of 
Ventriject. Anonymised data recording of the SCG data (generated by the Seismoﬁt® device), 
including the patient's height, weight, age, and sex, is sent via the internet to Ventriject, enabling 
the calculation of the VO2Peak. The identiﬁcation number of the speciﬁc device used at each 
measurement will be recorded alongside the unique study number, allowing for device 
traceability and accountability. There will be no storage of information or media device ﬁles on 
the researcher’s mobile phone while using the Ventriject VO2Max estimation algorithm.  
If patients lose capacity prior to surgery, they are unlikely to proceed to having major surgery. In 
the event that patients lose capacity, the data that was collected with active consent, such as 
the Seismoﬁt readings and CPET at baseline, will remain eligible for analysis as part of the 
study. 
All clinical study data will be analysed locally within an NHS / research infrastructure at GSTT 
and King’s College London to preserve data security and integrity. The chief investigator may 
delegate responsibilities for data entry, quality checking, and analysis but will ultimately be 
responsible for these tasks. Any data security breaches will be reported immediately to the data 
custodian for this study. 
The electronic data and paper ﬁles will be stored for ﬁve years before being deleted or securely 
destroyed. Data will not be transferred out of the EEA. 
The chief investigator will act as the data custodian. They will permit trial-related monitoring, 
audits, REC review and regulatory inspections, providing direct access to source 
data/documents. Trial participants are informed of this during the informed consent discussion. 
Participants will consent to provide access to their medical records. 
Study Organisation, Trial Monitoring and Management Strategy 
Study Management Responsibilities 

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The study's chief investigator will be responsible for the study's conduct and oversight. They will 
ensure that the trial is run in accordance with UK Policy Framework for Health and Social Care 
Research Guidelines, GCP, the local Guys and St Thomas’ NHS Foundation Trust Standard 
Operating Procedures and all other relevant regulatory requirements.  
The study Trial Management Group (TMG) will include the chief investigator, Trial Manager, Site 
PI’s and other personnel as appropriate. They will be responsible for running and managing the 
trial and data monitoring. They will hold regular teleconference / face-to-face meetings. The 
TMG’s terms of reference, roles and responsibilities will be deﬁned in the TMG charter. 
 
No responsibilities are delegated to the Seismoﬁt® Manufacturer (Ventriject). The trial 
monitoring plan will standardise and document that the investigation is conducted as described 
in this protocol. 
Study Early Termination / Suspension Criteria 
Early termination or suspension of the study may be implemented by the research ethics 
committee or local regulatory authority at the sponsor research site. Additionally, the chief 
investigator may decide to suspend enrolment in the clinical trial if deemed necessary. Reasons 
for suspension or early termination include safety issues, non-compliance, signiﬁcant concerns 
or an inspection or audit ﬁnding(s) of serious or repeated deviations on the part of the 
investigator(s). If the study is suspended or terminated, this will be communicated to all the 
participating research sites. 
The investigation will resume once necessary corrective measures have been implemented and 
deemed satisfactory by the sponsor site. 
End of Trial 
The study will end when 164 patients, who do not withdraw from the study have been recruited 
and their data is collected. The sponsor will notify the REC within 90 days of the date the last 
patient has their data collected. The ﬁndings and results of the trial will be analysed, and a ﬁnal 
study report will be produced within 12 months of study completion. 
Sponsor
Study Steering 
Committee
REC / Health 
Regulatory Authority
Clinicians 
Treating 
Patients
Research site 
PI/Research 
Nurses/Research
students
Local Institutional Clinical 
Governance at Research Sites
Patients
Ventriject 
Research 
Commercial 
Funding

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Trial Monitoring 
The Chief Investigator will be responsible for the ongoing management of the study.  The 
Sponsor will monitor and conduct audits on a selection of studies in its clinical research 
portfolio. Monitoring and auditing will be conducted in accordance with the UK Policy 
Framework for Health and Social Care and in accordance with the Sponsor’s monitoring and 
audit procedures 
Local site data monitoring by designated investigational leads and centralised data monitoring 
in conjunction with training provided in the use of the investigational device and the written 
guidance provided will be assumed to have the appropriate data monitoring in place for the 
purpose of this study.  
CPET will be conducted as per the local standard of care. For the purposes of this study and 
analysis of the ﬁnal data, CPET VO2Peak readings will be considered valid with each patient 
reaching maximal exertion where they reach the following criteria: 
1. Achieving >80% of the predicted maximum work of the patient (in Watts)  
2. Achieving maximum HR >80% (Predicted Maximum = 220 – Patient Age) (Chambers and 
Wisely, 2019; Levett et al., 2018b) 
3. Achieving a RER of >1.10 (Levett et al., 2018b) 
The monitoring activities' results will be reported to the sponsor, including the date, 
investigation site name, name of the monitor and investigation site leads.  
Day-to-day monitoring will be done by the trial management group as outlined in the study 
management responsibilities section to ensure that the data collected is: 
 
Consistent with the protocol and GCP 
 
No key data is missing 
 
Valid and consistent within the range of expected values. 
 
Completed only by the authorised research site staƯ. 
Monitoring visits by the central research team will list: 
 
Date of visit, site name and name of the monitor 
 
Name of the site PI or other research staƯ in attendance. 
 
A summary of the documents reviewed along with signiﬁcant ﬁndings, deviations, 
deﬁciencies and actions taken or recommended. 
Insurance and Liability 
Indemnity for the participating hospitals will be provided by the standard NHS indemnity 
arrangements. 
The study is co-sponsored by King’s College London (KCL) and (GSTT). The sponsors will, at all 
times, maintain adequate insurance in relation to the study. KCL through its’ own professional 
indemnity (Clinical Trials) & no-fault compensation and the GSTT having a duty of care to 
patients via NHS indemnity cover, in respect of any claims arising as a result of negligence by its 
employees, brought by or on behalf of a study participant. 
Contact with General Practitioner (GP) 

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As there is no change in management intervention within this study and no deviation from the 
routine clinical practice of either GSTT, UHS, RM or RS, the GP will not be informed of the 
subject’s involvement in the trial. 
Clinical Study Reporting Policy 
Clinical data will be presented at the end of the trial based on ﬁnal data listings.  The CI or a 
delegated individual will prepare a brief study report/publication based on the ﬁnal data listings.  
A summary of the report will be provided to the Research Ethics Committee within 1 year of 
submitting the end-of-trial notiﬁcation. 
Reporting and Publication 
The main trial results will be published in a peer-reviewed journal on behalf of all collaborators. 
The study team will prepare the manuscript with the results of the trial. Authorship will be based 
on the criteria set by the International Committee of Medical Journal Editors (ICJME). All 
participating clinicians will be acknowledged in the publication.  
At the time of consenting, participants will be given the opportunity to indicate on the consent 
form if they would like to receive updates on the study outcomes and to provide an email 
address to receive this information at the completion of the study. At the end of the study, 
participants who indicated they would like to receive updates on the outcomes will be provided 
with an email containing a lay summary of the outcomes, thanking them for their participation 
in the study and information on where the outcomes of the study are being presented and or 
published. 
Conﬂict of Interest 
The chief investigator and the research teams have no conﬂict of interest with this study. 
Ventriject, which makes the device, has funded the devices, adhesive patches, and the cost per 
test. Ventriject has not been involved in the writing of this research protocol. Ventriject has 
permitted researchers and clinical teams to publish ﬁndings in peer-reviewed literature, 
irrespective of the outcomes. Ventriject will have no input into the analysis of the outcome data. 
Devices will be returned to Ventriject at the end of the trial. 
Safety Reporting 
All adverse events and any new information concerning these shall be documented in a timely 
manner throughout the study period and reported to the sponsor. An interim or ﬁnal study  
report will note all adverse events. 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory ﬁnding) in subjects, users, or other persons, whether related 
to the participation in the study. This includes:  
 
Events related to the medical device. 
 
Events related to the procedures involved (any procedure in the study protocol). 
. 

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Serious Adverse Event (SAE) 
Adverse event that: 
 
Led to death, 
 
Led to a severe deterioration of health that either: 
 
Resulted in a life-threatening illness or injury, or; 
 
Resulted in a permanent impairment of a body structure or a body function, or; 
 
Required in-patient hospitalization or prolongation of existing hospitalization, or; 
 
Resulted in medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
 
Led to foetal distress, foetal death or a congenital abnormality or congenital disability. 
A planned hospitalisation for a pre-existing condition or a procedure required by the study 
protocol, without a severe deterioration of health, is not considered a serious adverse event.  
Investigator Responsibilities 
AE / SAE will be collected from the date of consent until all study measurements have been 
collected. All events will be recorded in the medical notes and the appropriate section of the 
study case reporting form and AE log.  
SAE will be reported to the sponsor. 
Assessment of Severity 
All adverse events will be graded for severity. The investigator will assess the severity of each 
adverse event, which should be recorded. 
NB: to avoid confusion or misunderstanding of the diƯerence between the terms “serious” and 
“severe”, the following note of clariﬁcation is provided: “Severe” is often used to describe the 
intensity of a speciﬁc event, which may be of relatively minor medical signiﬁcance.  
Assessment of Seriousness 
The seriousness of an AE is assessed by the PI (or delegate) using the criteria outlined above.  
Assessment of Causality 
All AEs will be evaluated by the PI (or delegate) for potential relationship to the study 
procedures. 
 
Unrelated: where an event is not considered related to participation in the study. 
 
Possibly related: the nature of the event, the underlying medical condition, concomitant 
medication, or temporal relationship make it possible that the AE has a causal 
relationship to participation in the study. 
The investigator must obtain suƯicient information to determine the causality or the AE (i.e., 
study protocol, other illness, progressive malignancy, etc.) and provide their opinion of the 
causal relationship between each AE and participation in the study. This may require instituting 
supplementary investigations of signiﬁcant AEs based on their clinical judgment of the likely 

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causative factors, which may include seeking a further opinion from a specialist in the ﬁeld of 
the AE. 
Assessment of Expectedness 
If the AE is judged to be related to the device, the PI (or delegate) will assess expectedness 
based on knowledge of the reaction and any relevant product information as documented in the 
risk analysis report. The event will be classed as either: 
 
Expected: the reaction is consistent with the eƯects of the device listed in the risk 
analysis report. 
 
Unexpected: the reaction is inconsistent with the eƯects in the risk analysis report. 
Reporting of Adverse Events  
Reportable events 
The following events are considered reportable: 
 
Any SAE 
 
New ﬁndings/updates about already reported events 
For each event, the following information will be collected: 
 
Full details in medical terms and case description 
 
Event duration (start and end dates, if applicable) 
 
Action taken 
 
Outcome 
 
Seriousness criteria 
 
Causality (i.e., relatedness to investigation), in the opinion of the investigator 
 
Whether the event would be considered expected or unexpected. 
All reportable events must be notiﬁed to the sponsor team and the Chief Investigator within 24 
hours of the site staƯ becoming aware of the event. The Sponsor has delegated the 
responsibility of informing the REC of reportable events to the CI. 
Any change of condition or other follow-up information should be emailed (through secure NHS 
Email account) to the CI within 24 hours of the information becoming available. Events will be 
followed up until the event has been resolved or an outcome has been reached.   
The CI will collaborate with the device manufacturer to notify the REC of reportable events. 
Reporting Timelines 
All SAE  which indicates an imminent risk of death, serious injury, or severe illness and that 
requires prompt remedial action for other patients/subjects, users or other persons or a new 
ﬁnding to it must be reported to the REC immediately, but not later than 15 calendar days after 
awareness by CI of a new reportable event or of new information in relation with an already 
reported event. 
Any other reportable events or a new ﬁnding/update to a reportable event must be reported to 
the REC immediately, but not later than seven calendar days following the date of awareness by 

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the CI of the new reportable event or of new information in relation with an already reported 
event. 
Funding 
FUNDER(S)
(Names and contact details of ALL 
organisations providing funding and 
support in kind for this study) 
FINANCIAL AND NON-FINANCIAL
SUPPORT GIVEN 
Ventriject 
£60,000 in total over 2 years plus 
Seismoﬁt® devices which will be returned 
to Ventriject at the end of the trial and use 
of proprietary algorithms in generation of 
VO2Max estimates 
 
Funding Schedule
Oct/24 
 £         8.000 
Jan/25 
 £         6.000 
Apr/25 
 £         6.000 
Jul/25 
 £         6.000 
Oct/25 
 £         8.000 
Jan/26 
 £         6.000 
Apr/26 
 £       10.000 
Jul/26 
 £       10.000 
Total 
 £       60.000 
 
 
Karolinska Institutet
£15,000 in total over two years
 
 

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APPENDIX 1 
SAE Reporting Flow Diagram-Non CTIMPs 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 2 
Information with regards to Safety Reporting in Non-CTIMP Research 
Who
When
How
To Whom
SAE (related 
and 
unexpected) 
Chief 
Investigator 
-Report to Sponsor 
within 24 hours of 
learning of the event 
 
-Report to the MREC 
within 15 days of 
learning of the event 
 
SAE Report form for Non-
CTIMPs, available from 
NRES website. 
Sponsor and 
MREC 
Urgent Safety 
Measures  
Chief 
Investigator 
Contact the Sponsor 
and MREC Immediately 
 
Within 3 days  
By phone
 
 
 
 
Substantial amendment 
form giving notice in writing 
setting out the reasons for 
the urgent safety measures 
and the plan for future 
action. 
Main REC and 
Sponsor  
 
 
 
Main REC with a 
copy also sent to 
the sponsor. The 
MREC will 
acknowledge this 
within 30 days of 
receipt.  
Progress 
Reports  
Chief 
Investigator 
Annually ( starting 12 
months after the date of 
favourable opinion) 
Note as of August 2024, 
NHS REC Annual Progress 
Reports are no longer 
mandated but may be 
requested for certain 
project types or by the 
project Sponsor 
NHS REC Annual 
Progress Reports 
are no longer 
mandated but may 
be requested for 
certain project 
types or by the 
project Sponsor 
Declaration of 
the 
conclusion or 
early 
termination of 
the study 
Chief 
Investigator 
Within 90 days 
(conclusion) 
 
Within 15 days (early 
termination) 
 
The end of study should 
be deﬁned in the 
protocol 
End of Study Declaration 
form available from the 
NRES website 
Main REC with a 
copy to be sent to 
the sponsor  
Summary of 
ﬁnal Report  
Chief 
Investigator 
Within one year of 
conclusion of the 
Research 
No Standard Format
However, the following 
Information should be 
included:- 
Where the study has met 
its objectives, the main 
ﬁndings and arrangements 
for publication or 
Main REC with a 
copy to be sent to 
the sponsor 

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dissemination including 
feedback to participants 
 
 
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https://doi.org/10.1016/j.bjae.2019.01.009. 
Conﬁdentiality, S. O. F. (2011) Investigator ’ S Brochure Investigator ’ S Brochure ( Ib ). Plexxikon 
Investigator’s Brochure. (December), 1–110. 
Hansen, M. T. et al. (2023a) Validity and reliability of seismocardiography for the estimation of 
cardiorespiratory ﬁtness. Cardiovascular Digital Health Journal. [Online] 4 (5), 155–163. 
Hansen, M. T. et al. (2023b) Validity and reliability of seismocardiography for the estimation of 
cardiorespiratory ﬁtness. Cardiovascular Digital Health Journal. [Online] 4 (5), 155–163. 
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using Seismocardiography This is an Accepted Manuscript of an article published by 
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Levett, D. Z. H. et al. (2018a) Perioperative cardiopulmonary exercise testing (CPET): consensus 
clinical guidelines on indications, organization, conduct, and physiological interpretation. 
British Journal of Anaesthesia. [Online] 120 (3), 484–500. 
Levett, D. Z. H. et al. (2018b) Perioperative cardiopulmonary exercise testing (CPET): consensus 
clinical guidelines on indications, organization, conduct, and physiological interpretation. 
British Journal of Anaesthesia. [Online] 120 (3), 484–500. [online]. Available from: 
https://doi.org/10.1016/j.bja.2017.10.020. 
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Evaluation of Seismoﬁt® as a tool for assessing ﬁtness and predicting outcomes in 
Oesophageal cancer surgery  
Protocol Ver 1.0 
Protocol Date: 08/04/2025 
IRAS ID - 342434 
26 
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