CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
wireless pH capsule recordingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04268719
NCT04268719N/ACompleted

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

King's College Hospital NHS Trust·observational·Posted Feb 13, 2020·Updated Feb 13, 2020

In Brief

An observational study evaluating wireless pH capsule recording for Gastro Esophageal Reflux. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 13, 2020
Enrollment StartNov 23, 2017
Primary CompletionJul 26, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.4 years ago

Interventions

wireless pH capsule recordingother

wireless pH capsule recording for up to 96 hours