NCT02385045

Brief Summary

This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

May 9, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 5, 2015

Results QC Date

October 12, 2021

Last Update Submit

May 5, 2022

Conditions

Gastritis

Outcome Measures

Primary Outcomes (1)

  • Successful Diagnosis of Helicobacter Pylori Using Imaging Modality

    The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques

    1 year

Study Arms (2)

Narrow band imaging

PLACEBO COMPARATOR

Narrow band imaging function (Olympus endoscopes)

Device: narrow band imaging

i-scan imaging

EXPERIMENTAL

i-scan imaging (Pentax endoscopes)

Device: i-scan

Interventions

i-scanDEVICE

i-scan function is located on the head of the Pentax endoscopes

i-scan imaging
narrow band imagingDEVICE

narrow band imaging function is located on the head of Olympus endoscopes

Narrow band imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain

You may not qualify if:

  • Patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation.
  • Patients with a known diagnosis e.g. upper gastrointestinal cancer
  • Patients previously treated with HP eradication therapy
  • Patients who had taken PPI, H2 receptor antagonists and antibiotics within 4 weeks
  • Patients with acute gastrointestinal bleeding
  • Patients who'd had previous gastric surgery
  • Patients with chronic liver disease
  • Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
  • Patients who are unable or unwilling to give informed consent
  • Patients under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, Greater London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Glover B, Teare J, Patel N. Assessment of Helicobacter pylori status by examination of gastric mucosal patterns: diagnostic accuracy of white-light endoscopy and narrow-band imaging. BMJ Open Gastroenterol. 2021 Aug;8(1):e000608. doi: 10.1136/bmjgast-2021-000608.

    PMID: 34353822DERIVED

MeSH Terms

Conditions

Gastritis

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Professor Julian Teare
Organization
Imperial College London
j.teare@ic.ac.uk
02033126666

Study Officials

  • Julian Teare

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 9, 2022

Results First Posted

May 9, 2022

Record last verified: 2022-05

Locations

GB(1)