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Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268719
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief Summary:
Gastro-oesophageal reflux disease (GORD) is a chronic condition with symptoms arising secondary to the reflux of stomach contents (Vakil et al., 2006). It is divided into four phenotypes: Erosive Oesophagitis (EO), Non-Erosive Reflux Disease (NERD), Reflux Hypersensitivity (RH), Functional Heartburn (FH) (Nikaki, Woodland and Sifrim, 2016). The definition of these phenotype have evolved with the addition of diagnostic tests and methods of their interpretation, the most recent being the Lyon Consensus Statement (Gyawali et al., 2018). The majority of patients presenting with symptoms suggestive of GORD have no mucosal lesion seen at endoscopy (Nikaki, Woodland and Sifrim, 2016). Studies have shown a relation of increased IPCL numbers with GORD. This study aims to build a fully autmoated AI model using Near-Focus NBI images on patients with symptoms suggestive of GORD phenotyped in accordance with the Lyon Consensus.

Condition or disease Intervention/treatment
Gastro Esophageal Reflux Diagnostic Test: wireless pH capsule recording

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Gastro-Esophageal Reflux Disease
Patients defined as having GERD as per Lyon Consensus
Diagnostic Test: wireless pH capsule recording
wireless pH capsule recording for up to 96 hours

Non-acid Reflux
Patient excluded for GERD as per Lyon Consensus
Diagnostic Test: wireless pH capsule recording
wireless pH capsule recording for up to 96 hours




Primary Outcome Measures :
  1. To evaluate Intra-Papillary Capillary Loop (IPCL) changes secondary to oesophageal acid exposure. [ Time Frame: 6 weeks post completion of wireless capsule pH recording ]
    Parameters of IPCLs: IPCLs/region of interest, morphology: IPCL length, density correlated to oesophageal acid exposure

  2. To develop an accurate and reliable artificial intelligence model for the diagnosis of Gastro-Oesophageal Reflux Disease (GORD) [ Time Frame: 3 months after completion of all data collection ]
    Patient data split into training/validation and test dataset for computer assisted and deep learning model training and testing


Secondary Outcome Measures :
  1. To explore factors that may predict response to treatment. [ Time Frame: 6 weeks to include data of response to antacid treatment ]
    Statistical analysis of models for IPCL number/ROI and morphology features against response to an antacid medication challenge.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients attending the Gastroenterology department for the investigation of symptoms suggestive of Gastro-Oesophageal Reflux Disease (GORD) were approached for recruitment. Patients had to have symptoms including heartburn, regurgitation or chest/epigastric pain for a minimum of 3 months.
Criteria

Inclusion Criteria:

  • Retaining capacity and medically fit for gastroscopy
  • Requiring gastroscopy by current BSG guidelines for the investigation of acid reflux/ dyspepsia

Exclusion Criteria:

  • Unable to give informed consent
  • History of oesophageal or gastric surgery
  • Allergy to proton-pump inhibitor
  • Known Barrett's Oesophagus/ oesophageal carcinoma/ oesophageal stricture/ known oesophageal dysmotility
  • Portal Hypertension
  • Pacemaker (BRAVO)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268719


Locations
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United Kingdom
Shraddha Gulati
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Publications:

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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04268719    
Other Study ID Numbers: 227223
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Protocol possible to obtain upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases