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The X-ray imaging capsule overcomes the requirement for bowel preparation, a major deterrent for colorectal cancer (CRC) screening. This prospective multicentre study examined capsule safety and efficacy (compared with fecal immunochemical test (FIT)) for polyp detection confirmed by ensuing colonoscopy. In 45 analysed patients, capsule and FIT sensitivity for polyps was 44% and 37%, respectively. Capsule sensitivity increased to 78% when >50% of the colon surface area was imaged, with a linear correlation between imaged area and sensitivity. An updated scanning algorithm, retrospectively implemented on these study data, dramatically increased numbers of subjects with imaged area >50%, from 21 to 41/45 (46% to 91%). Capsule specificity for polyps approached 90%. Transit time was 52±32 hours. No device-related serious adverse events occurred. Average X-ray dose was 0.05 mSv.
In more detail
Many patients forego screening by colonoscopy due to the need for cathartic preparation,1 2 posing a major obstacle to implementation of current screening programmes.3 4 A test not requiring laxative preparation could increase adherence with screening.1 Moreover, inadequate preparation for colonoscopy impairs adenoma and cancer detection rates and often necessitates repeating of the procedure.5 A prep-less modality would not suffer from these limitations. In a previous proof-of-concept study, a prep-less screening capsule was shown to be safe, capable of 3D reconstruction of the colonic wall and lumen and identifying adenomatous polyps.6 In a prospective multicentre comparative study, we studied the safety and efficacy of a first version of the capsule for identifying colonic polypoid lesions and masses compared with FIT and colonoscopy.
The system has …
NG and EEH contributed equally.
Contributors NG, EEH: acquisition of data, drafting the manuscript. MM: study design, acquisition of data. NA: study design, acquisition of data, critical review of manuscript. JL, DS, AK, VB, YR, IG, MSL: acquisition of data.
Funding The study was funded by Check-Cap Ltd, Mount Carmel, Israel.
Competing interests NG and NA report receiving consulting fees from Check Cap Ltd.
Patient consent Not required.
Ethics approval IRB in all participating sites, as well as by the national ethics committee of the Israeli Ministry of Health.
Provenance and peer review Not commissioned; internally peer reviewed.