Authors' objectives: Patients with chronic reflux or gastro-oesophageal reflux disease (GORD) can develop the precancerous condition Barrett’s oesophagus, which may then progress to oesophageal cancer. The prognosis of oesophageal cancer is poor as the early stages may be asymptomatic and patients often do not present until it is advanced. Patients with GORD may be offered upper gastrointestinal tract endoscopy to check for Barrett’s oesophagus or signs of cancer and those with confirmed Barrett’s oesophagus are recommended to receive regular endoscopic surveillance. However, the majority of people undergoing endoscopy will be found not to have these conditions and the current wait times for endoscopy in Wales are very long, with significant pressure on the service. Capsule sponge testing can be used as a triage and risk stratification test to determine whether endoscopy is required, how urgently, and how frequently for surveillance. HTW searched for evidence that could be used to answer the review question: what is the clinical effectiveness and cost effectiveness of capsule sponge devices to detect Barrett’s oesophagus and early-stage oesophageal cancer?

Authors' results and conclusions: We identified four clinical guidelines and 17 studies: one health technology assessment, one randomised controlled trial, 12 observational studies, and four economic studies (one of which was one of the 12 observational studies). The evidence suggests the diagnostic accuracy of capsule sponge devices with trefoil factor 3 (TFF3) testing for proactive screening of Barrett’s oesophagus in those with chronic reflux is good, with high sensitivity and specificity. Where reported, positive predictive value (PPV) is low whilst negative predictive value (NPV) is high. For case finding of Barrett’s oesophagus using capsule sponge testing with TFF3, p53, and cellular atypia, detection rates suggest potentially high rates of false positives but very low rates of false negatives. The diagnostic accuracy for case finding also appears to be good, with sensitivity above 90%, and PPV and NPV findings supporting the findings from detection rates. Capsule sponge testing with p53 and cellular atypia for Barrett’s oesophagus under surveillance also shows good accuracy for detecting dysplasia or cancer and is effective in risk stratifying Barrett’s oesophagus patients. The safety of capsule sponge devices appears to be high, and the incidence of adverse events is low.

Authors' recommendations: The evidence supports the routine adoption of capsule sponge devices with relevant biomarker testing (TFF3, p53, cellular atypia) within the diagnostic pathway for Barrett’s oesophagus in people with chronic reflux. Capsule sponge testing demonstrates good diagnostic accuracy for the detection of Barrett’s oesophagus. Adding capsule sponge testing to the diagnostic pathway for Barrett’s oesophagus in people with chronic reflux, whilst slightly reducing the benefit to patients, was estimated to be cost-effective. The evidence is insufficient to support routine adoption of capsule sponge testing for Barrett’s oesophagus surveillance due to a lack of clinical outcomes to determine cost effectiveness.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Authors' identified further research: HTW recommends further evidence generation on the impact of capsule sponge testing on time to diagnosis and treatment, long term clinical outcomes, and longitudinal diagnostic accuracy in those undergoing surveillance.

Project Status: Completed

Year Published: 2026

URL for published report: https://healthtechnology.wales/reports-guidance/capsule-sponge-devices/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk