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Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery

NCT07159711 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2025-09-08

No results posted yet for this study

Summary

Oesophageal cancer is a common cause of cancer death worldwide. Curative treatment involves chemotherapy and surgery but has significant risks. Therefore, patient selection and improving physical fitness to withstand such major treatment is important to reduce the risk of complications. Physical fitness is traditionally measured by a specialised exercise test called Cardiopulmonary exercise testing (CPET), which can take up to one hour and requires specialised staff and expensive equipment such as a graded exercise bike or treadmill. Seismofit is a small device (smaller than a smartphone) used to estimate fitness in patients in under three minutes while lying down at rest. It measures the vibrations generated by the heart and, together with patient height, weight, age, and gender, accurately estimates fitness using an algorithm developed in healthy patients. The device has never been tested in a large group of oesophageal cancer patients to see if it can be used to predict complications in patients undergoing cancer treatment.

In this study, patients undergoing Oesophageal cancer treatment with chemotherapy or chemoradiotherapy and surgery will have Seismofit measurements at various points during their treatment to see if we can predict complications and hospital stay. Secondly, this study will also evaluate the accuracy of Seismofit compared to the gold standard CPET results in cancer patients.

Conditions

  • Oesophageal Cancer
  • Oesophageal Adenocarcinoma
  • Prehabilitation
  • Oesophagectomy
  • Neoadjuvant Chemotherapy

Interventions

DIAGNOSTIC_TEST

Seismofit

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 afixed 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. 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 app.

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Davies, MD FRCS · Guy's and St Thomas NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-06-01
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159711 on ClinicalTrials.gov