OC-003 Feasibility and performance characteristics of a novel disposable transnasal capsule device for barrett’s oesophagusscreening: an international multicentre trial

2017 
Introduction Screening for Barrett’s oesophagus (BO) with standard endoscopy (SE) is expensive. Unsedated transnasal endoscopy (uTNE) is a feasible and safe alternative for BO screening. We aimed to assess the technical feasibility, safety and performance characteristics of clinic-based uTNE using a novel single use transnasal capsule-based device (EG Scan II) compared to SE. Method A prospective study was conducted at three centres (2 United Kingdom, 1 United States). Patients referred for clinical SE with and without known BO were invited to participate. uTNE with the EG Scan device (consisting of a 6 mm diameter disposable capsule attached to a controller and air compressor) was performed first followed by SE. Both procedures were conducted by different endoscopists blinded to the indication and outcome of either procedure. Results of the SE were considered as the gold standard. Patient symptoms (gagging, choking, discomfort, nasal pain) were recorded on a 10-point visual analogue scale (VAS) (10 being the worst), in addition to overall preference and experience on a 10-point VAS (10 being the best). Results 200 patients, 100 with and 100 without known BO, 33% females and mean age (+/- standard deviation) of 57.8 years (+/-14) participated. Median (IQR) length of the BO segment was 2 (1-4) cm. 178 (89%) patients completed both procedures. 22 (11%) did not complete the EG Scan exam (1 poor tolerability after intubation, 21 inability to traverse nasal passages). The median symptom scores for the EG Scan were excellent ranging from 0–2. Overall experience was good with a median VAS score of 8 for the EG Scan, compared to 7 for SE. 54.5% of the participants preferred the EG Scan, while 16.8% preferred SE. 1 patient developed self-limiting epistaxis following uTNE. Sensitivity and specificity of EG Scan for BO diagnosis was 89.4% (95% confidence interval (CI) 83.3–95.6) and 90.3% (95% CI 84–96.7) respectively. Sensitivity was superior for long segment BO (93%) than short segment BO (87%). Conclusion uTNE with the EG Scan device is a safe, well-tolerated and accurate alternative for BO screening. Thus, it could potentially serve as a community and office based tool for BO screening. Disclosure of Interest S. Sami: None Declared, P. Pophali: None Declared, M. Halland: None Declared, M. Di Pietro: None Declared, J. Ortiz-Fernandez-Sordo: None Declared, J. White: None Declared, M. Johnson: None Declared, I. Guha: None Declared, R. Fitzgerald: None Declared, P. Iyer Conflict with: Intromedic Ltd., K. Ragunath Conflict with: Intromedic Ltd.
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