AI-Assisted Double-Headed Capsule Endoscopy: Multicentre Prospective Diagnostic Accuracy Study Across Small Bowel Indications.

Background/Aims: Double-headed capsule endoscopy enhances visualization and diagnostic yield in small bowel evaluation but increases reading time. This study aimed to assess the diagnostic performance of AI-assisted double-headed capsule endoscopy (MiroCam MC2000) across all small bowel indications and to compare its reading efficiency with the standard manual reading mode.

Methods

From May to December 2023, 242 consecutive patients (mean age 50.17 years, SD 18.3; 53% female) underwent small bowel capsule endoscopy at two UK centres for suspected Crohn's disease (48.8%), iron-deficiency anemia (23.6%), bleeding (18.6%), or other (9%). Seven experienced readers reviewed videos in standard mode (blinded to clinical data), then AI-assisted (MiroCam AI Scan) methods were applied after de-identification/randomization. Two experts provided reference standards. No adverse events occurred.

Results

AI-assisted reading had sensitivity 95.3% (95% CI 90.1-98.3%) and specificity 96.5% (95% CI 91.3-99.0%) for diagnostic findings, vs. standard reading: 96.5% (95% CI 91.2-99.0%) and 85.3% (95% CI 78.0-90.9%). The positive findings rate was 83.6% vs. 80.2% (p = 0.040). Reading time decreased by 52% (38.1 vs. 18.26 min; p < 0.001).

Conclusions

AI-assisted reading offers high diagnostic accuracy, superior specificity and reduced reading times, supporting its adjunctive role with expert oversight. Registered: ERGO ID 82419.