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

April 24, 2024 updated by: University of Exeter
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Barrett's oesophagus

Exclusion Criteria:

  • Unfit for endoscopic and biopsy assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adenocarcinoma
patients diagnosed with adenocarcinoma
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Squamous cell cancer
patients diagnosed with squamous cell cancer
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Other
patients diagnosed with another condition
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Barrett's oesophagus
patients diagnosed with Barrett's oesophagus
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Low-grade dysplasia
patients diagnosed with low-grade dysplasia
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: High-grade dysplasia
patients diagnosed with high-grade dysplasia
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Indefinite for dysplasia
patients where the diagnosis is unclear
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: no dysplasia
patients not diagnosed with any cancer
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Exeter

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bristol
Gloucestershire Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oliver Old, BMedSc MBChB, Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1516/017/162347
  • II-LB-0315-20008 (Other Grant/Funding Number: NIHR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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