Introduction of a novel capsule sponge device for Barrett's surveillance - A Swedish multicenter feasibility study

Barrett's esophagus (BE) surveillance relies on endoscopy, which can limit accessibility and strain healthcare resources, a challenge in Nordic countries. Non-endoscopic alternatives could improve surveillance efficiency, but implementation data are limited. We assessed the feasibility of implementing EndoSign^®, a novel capsule sponge, in Sweden.

This prospective, multicenter feasibility study across five Swedish hospitals (Dec 2023-Oct 2024), recruited 70 adults with histologically-confirmed BE undergoing routine surveillance. Trained nurses performed the capsule sponge procedure, with samples analyzed centrally for TFF3, atypia and p53. Feasibility objectives were technical success, patient acceptability and safety. We also assessed sample adequacy and risk stratification.

Of 70 enrolled patients (median age 68 years [IQR 63-72]; 84.3% male), 68 (97.1%) completed the procedure successfully. Patient acceptability was high; median discomfort was 2/10 [IQR 1-3] during the procedure, decreasing to 0/10 [IQR 0-1] after 15 min. Most patients (71.4%) preferred the capsule sponge over gastroscopy. Minor adverse events (sore throat) were present in three patients (4.3%) at 7 days and one patient (1.4%) at 90 days; no serious adverse events were reported. Sample adequacy was 92.6% (63/68). Risk stratification (n = 60) categorized 20.0% as high-risk, leading to expedited endoscopy.

This capsule sponge demonstrated successful implementation with high technical success, patient acceptability and safety. The nurse-led delivery model proved effective, supporting potential broader implementation. This technology could provide a viable, patient-centered component of BE surveillance, though larger validation studies are needed.

ClinicalTrials.gov Identifier: NCT07036432.