Clinical Trial: Capsule Sponge as a Non‐Endoscopic Monitoring Tool in Eosinophilic Oesophagitis—A Prospective Real–World Multicentre Study
Rohith Kumar, Ayesha Rai, Kim Shaw, Erzsebet Santa, Francoise Cole, Hyesha McDonald, Pearl Baker, Lisa Mears, Anjan Dhar, Guiomar Moral‐Villarejo, Jacobo Ortiz Fernández‐Sordo, Ashraf Sanduka, Maria O'Donovan, Radina Georgieva, Sarah Killcoyne, Danielle L. MorrisABSTRACT
Background and Aims
Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition requiring repeat endoscopy and biopsy for histological monitoring, which is invasive, resource‐intensive and burdensome for patients. The capsule sponge (CS) offers a potential non‐invasive alternative. We evaluated the diagnostic accuracy, feasibility and patient acceptability of CS versus endoscopic biopsies for monitoring disease activity in adult patients.
Methods
A real‐world prospective multicentre cohort study was conducted across three NHS sites in England from August 2023 to June 2025. Adults with established EoE without oesophageal strictures underwent same‐day endoscopy and CS using the Endosign device. Histological activity was defined as ≥ 15 eosinophils per high‐power field or 0.3 mm 2 on endoscopic biopsy histology and CS respectively. Symptom burden was assessed using the Dysphagia Symptom Questionnaire, endoscopic severity using the EoE Endoscopic Reference Score and patient acceptability via structured questionnaire.
Results
136 patients (164 paired episodes) from three secondary care hospitals successfully swallowed CS with sufficient sampling; CS swallowing success rate was 92.7%. Median age was 45 years (IQR 34.8–56); 92/136 (67.6%) were male. CS demonstrated sensitivity 76.3%, specificity 89.5%, PPV 80.4%, NPV 87.0% and overall accuracy 84.8% (Cohen's κ = 0.67). AUC was 0.904 (95% CI 0.856–0.953). Patient acceptability recorded 96.7% found CS acceptable, 78.8% preferred it over endoscopy, and 90.8% would repeat the procedure. No complications occurred.
Conclusions
CS is a safe, feasible, accurate and highly acceptable less‐invasive tool for monitoring EoE. Its implementation could improve care pathways, reducing the need for repeated endoscopic biopsies while maintaining diagnostic reliability, with potential to reduce service burden, carbon emissions and improve patient experience.
Trial Registration
CoSiE: IRAS number: 314770;