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Detection of Barrett's esophagus (BE) at points of care outside the endoscopysuite may improve screening access and reduce esophageal adenocarcinomamortality. Tethered capsule optical coherence tomography (OCT) canvolumetrically image esophageal mucosa and detect BE in unsedated patients. Weinvestigated ultrahigh-speed tethered capsule, swept-source OCT (SS-OCT) inunsedated patients, improved device design, developed procedural techniques,measured how capsule contact and longitudinal pullback non-uniformity affectcoverage, and assessed patient toleration. OCT was performed in 16 patientsprior to endoscopic surveillance/treatment. Unsedated patients swallowed thecapsule with small sips of water and the esophagus imaged by retracting thetether. Ultrahigh-speed SS-OCT at 1,000,000 A-scans/second imaged ~40cm$^2$esophageal areas in 10 seconds with 30um transverse and 8um axial resolution.Nine patients had non-dysplastic BE, 3 had ablative treatment-naive neoplasia,and 4 had prior ablation for history of dysplasia. The capsule procedure waswell tolerated. Ultrahigh-speed SS-OCT enabled the generation ofcross-sectional and sub-surface en face images. BE could be rapidly identifiedin cross-sectional and en face images, while assessment of thegastro-esophageal junction (GEJ) required subsurface en face views. Capsuleesophageal contact was worse in long-segment BE and sliding hiatal hernia, andlongitudinal image coverage was worse in short-segment BE. OCT candidatefeatures of dysplasia are reported. Ultrahigh-speed tethered capsule SS-OCTenabled en face and cross-sectional imaging of mucosal features over wideareas. Device and procedure optimization led to improved imaging performance.Areas of BE could be readily identified, but limited capsule contact andlongitudinal image coverage can yield sampling errors.

Tethered capsule en face optical coherence tomography for imaging Barrett's esophagus in unsedated patients