Assessing motility of the gastrointestinal tract using a wireless capsule

4.1 A systematic review of 745 patients (12 studies) with suspected motility problems reported sensitivity of the wireless motility capsule in comparison with clinical diagnosis of gastroparesis to be 65 to 68% and specificity to be 82 to 87% in a subset of 560 patients (reported by 7 studies included in the systematic review).

4.2 The systematic review of 745 patients (12 studies) with suspected motility problems reported sensitivity of the capsule in comparison with gastric emptying scintigraphy to be 59 to 86% and specificity to be 64 to 81% in a subset of 560 patients (reported by 7 studies included in the systematic review).

4.3 The systematic review of 745 patients (12 studies) with suspected motility problems reported sensitivity of the capsule compared with a radiopaque marker to be 37% and specificity to be 95% in a subset of 78 patients (reported by 1 study included in the systematic review) with constipation. A case series of 187 patients with constipation reported sensitivity of the capsule in comparison with radiopaque marker assessment for colonic transit time of 80% (95% confidence interval [CI] 67 to 98%, p=0.01) and specificity of 91% (95% CI 83 to 96%, p=0.00001). The same study reported sensitivity of the capsule in comparison with radiopaque marker assessment for small and large bowel transit time of 79% (95% CI 67 to 89%, p=0.01) and specificity of 91% (95% CI 83 to 96%, p=0.00001).

4.4 A case series of 86 patients with suspected symptoms of upper GI or lower GI dysmotility reported that using the capsule confirmed the clinical diagnosis in 58% (50/86) of patients and that radiopaque marker examination or gastric emptying scintigraphy confirmed the clinical diagnosis in 44% (38/86) of patients (p<0.05).

4.5 A case series of 83 patients with suspected gastroparesis, intestinal dysmotility or slow transit constipation reported that in 53% (44/83) of patients, using the capsule led to a new diagnosis. In a case series of 43 patients with gastroparesis comparing the capsule with gastric emptying scintigraphy, the reported overall diagnostic gain with the capsule (defined as the difference between the percentage of patients with abnormal motility detected by the capsule but normal scintigraphy, and the percentage of patients with normal capsule findings but abnormal scintigraphy) was 19% (p=0.04).

4.6 The systematic review of 745 patients (12 studies) with suspected motility problems reported data from a subset of 3 studies. In these 3 studies, using the wireless capsule altered management (medicine, diet or surgery) in 50 to 69% of patients with suspected gastroparesis.

4.7 The specialist advisers listed key efficacy outcomes as pan‑enteric measurement of transit (units of time) and motility (units of pressure or descriptive measures) in gut regions.