Clinical trial · Interventional
Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus
Prospective Pilot Cohort Study to Assess Early Diagnostic Utility of Hyper-Spectral Endoscopy for Detection of Neoplasia in Barrett's Oesophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1) Classification of spectral patterns corresponding to neoplastic vs non-neoplastic Barrett's; 2) Image quality assessed by the endoscopist by VAS rating the level of confidence in delineating the area of interest; 3) Time to perform hyperspectral imaging; 4) Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns. Participants will firstly undergo a standard endoscopy, followed by another endoscopy using the experimental HySe device. Subsequently, patients will receive biopsies according to Seattle protocol, and up to 6 additional (optional) snap frozen research biopsies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyper-Spectral Endoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard + Experimental Endoscopy
- description
- The endoscopist will intubate the patient with a high resolution white light endoscope (Olympus GIFH290Z or GIF-EZ1500) and thoroughly inspect the mucosal surface of the oesophagus. A careful note will be made of any visible lesion with their location, and the surrounding mucosa will be marked with cautery to localize the lesion for further hyperspectral imaging and biopsy. We will aim to identify at least two areas of interest per patient with the possibility to select more if the length of the Barrett's oesophagus allows. The endoscopist will remove the standard of care endoscope and then reintubate the patient with the experimental device and perform unbiased imaging first followed by targeted imaging of the endoscopic areas previously marked
- interventionNames
- Device: Hyper-Spectral Endoscopy
Primary outcomes (1)
- measure
- Contrast of neoplastic vs non-neoplastic Barrett's
- timeFrame
- Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure
- description
- Pixel intensity value at 16 different wave lengths in endoscopic areas of interest as compared with standard-of-care RGB white light endoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available