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Completed

NCT Number: NCT03468634

Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy

To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

About this study

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. The investigators intend to use this technique, known as "Raman Spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. It has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists.

A miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). This project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Barrett's oesophagus

Exclusion criteria

  • Unfit for endoscopic and biopsy assessment

Treatment and study plan

endoscopy

Diagnostic Test

Oesophageal endoscopy with biopsy

Other names: EGD (esophagogastro duodenoscopy), upper GI endoscopy

Primary outcomes

  1. Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)

    Time frame: 6 months

    Testing of the device for clinical application to demonstrate its use is safe and that is able to acquire diagnostic-quality (see outcome 2) spectra in less than 5 seconds from within the oesophagus.

    Samples illuminated will be biopsied and sent for routine histopathological analysis.

Secondary outcomes

  1. Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)

    Time frame: 6 months

    Computer model using multivariate analysis able to discriminate between diseased and non-diseased tissue. The target specificity and sensitivity are low due to small study group sizes.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust
  • University of Bristol

Registry information

Acronym: RaPIDE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2018
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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