NCT04478929

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

July 15, 2020

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • gastroscopy image data set

    Images collected during routine gastroscopy with examination notes

    12 months

Study Arms (1)

gastroscopy clinic patients

NBT gastroscopy clinic invited participants. Patients are already due to attend the clinic, and we are inviting them to share their gastroscopy data with our research study.

Diagnostic Test: Gastroscopy

Interventions

GastroscopyDIAGNOSTIC_TEST

Routine gastroscopy

gastroscopy clinic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Attending NBT clinic for on OGD phase 1, then later attending NBT clinic due to suspected Barrett's.

You may qualify if:

  • Adult
  • Attending Southmead Hospital for on OGD
  • Has capacity
  • Initially any indication, later patients with known Barrett's oesophagus

You may not qualify if:

  • Children (\<18)
  • Patients without capacity
  • Urgent and emergency procedures
  • Limited English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NBT, Southmead Hospital

Bristol, Avon, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Lyndon Winstone, PhD

CONTACT

benjamin winstone, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Officer

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 21, 2020

Study Start

August 1, 2020

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations