Status:
UNKNOWN
Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
University of Manchester
Conditions:
Endoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to assess the efficacy of hyperspectral endoscopic imaging to distinguish neoplasia from non-dysplastic Barrett's oesophagus in vivo. The main outcome measures are: ...
Detailed Description
This trial is designed to evaluate the feasibility of hyperspectral endoscopic imaging in vivo. The team has developed a custom hyperspectral endoscope based around a commercially available, standard...
Eligibility Criteria
Inclusion
- Male or female subjects over 18 years.
- Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm if circumferential (C≥2 according to Prague classification) or 3 cm if not circumferential (maximal extent M≥3, according to Prague classification).
- Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy.
Exclusion
- History of oesophageal stricture precluding passage of the endoscope.
- Pregnancy, or planned pregnancy during the course of the study.
- Currently breastfeeding.
- Any history of oesophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B \& C) or evidence of varices on initial treatment endoscopy.
- Any history of oesophageal surgery, except for uncomplicated fundoplication.
- History of coagulopathy, with INR\>1.3 and/or platelet count of \<75,000.
- On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06119906
Start Date
April 1 2024
End Date
June 30 2025
Last Update
November 7 2023
Active Locations (1)
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1
Cambridge University Hospital
Cambridge, County (optional), United Kingdom, CB20QQ