N/A
N=157
i-Scan for the Detection of Helicobacter Pylori
Gastritis
Bottom Line
View on ClinicalTrials.gov: NCT02385045 ↗Enrolled (actual)
157
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Successful Diagnosis of Helicobacter Pylori Using Imaging Modality — 28; 125 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- i-scan (Device); narrow band imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Diagnosis of Helicobacter Pylori Using Imaging Modality |
28; 125 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02385045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.