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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04478929
Other study ID # REDM0227_RP01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2020
Est. completion date August 2021

Study information

Verified date July 2020
Source University of the West of England
Contact Lyndon Winstone, PhD
Phone +4411732 82009
Email Lyndon.Smith@uwe.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Barrett's oesophagus is a condition in which the area between the oesophagus and stomach no longer closes, allowing acidic contents of the stomach to enter the oesophagus and damage the lining. The project aims to assist clinicians by offering informed biopsy process, in which the system presents the operator with clinical outcomes of patients with visually similar GI tracts. The project goal is to assess the use of artificial intelligence-based similarity detection systems to better inform biopsy placement, increasing the reliability of bi-yearly inspections.


Description:

The project intention is to acquire secondary endoscopy captured data from clinicians to create a sufficient dataset to train a learning system to achieve the stated objective. The data required will feature footage (images/videos) from inside the oesophagus. The preferred data would contain associated diagnosis notes and description, however, data without diagnosis can still be used. All data can and will be anonymised, as personal information will not be useful in this work.

The data will be labelled by either researchers, or professional clinicians and prepared ready to feed into a chosen learning AI system. Through an iterative learning process, the chosen AI system will learn to discriminate between severity of Barrett's oesophagus and output optimal biopsy target.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date August 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult

- Attending Southmead Hospital for on OGD

- Has capacity

- Initially any indication, later patients with known Barrett's oesophagus

Exclusion Criteria:

- Children (<18)

- Patients without capacity

- Urgent and emergency procedures

- Limited English

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Gastroscopy
Routine gastroscopy

Locations

Country Name City State
United Kingdom NBT, Southmead Hospital Bristol Avon

Sponsors (2)

Lead Sponsor Collaborator
Leigh Taylor Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary gastroscopy image data set Images collected during routine gastroscopy with examination notes 12 months
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