Purpose: CE has become a standard tool for evaluating the small bowel but there have been concerns regarding the risk of capsule retention in certain high risk groups. Using radiographic modalities to predict which patients are at risk of having a retained capsule has been shown to be inaccurate. Consequently, a radiation-free tool was developed to assess whether patients may safely undergo CE. The agile™ patency system (Given Imaging), an ingestible and dissolvable capsule with an external scanner, was developed to allow physicians to perform CE with greater confidence that the capsule will be safely excreted in patients at risk of capsule retention. Initial studies of an earlier version of this patency capsule demonstrated several cases where this device may have led to a partial obstruction. A new design of the capsule employs two timer plugs, one at each end, that allows the capsule to begin to dissolve at 30 hours after ingestion, thereby reducing the risk of obstruction if there is a stricture. This international, multi-center study was designed to assess the safety of the patency capsule in patients with known strictures and its ability to help physicians identify which patients may safely undergo CE. Methods: After informed consent, patients with known intestinal strictures ingested the new patency capsule. They underwent periodic scanning with a handheld scanner as well as fluoroscopy until the capsule was excreted. The intestinal tract was considered to be sufficiently patent if the capsule was excreted intact, or if the capsule was not detected by the scanner at 30 hours after ingestion. If patency was established, then the patient underwent CE with the PillCam™ SB capsule. Results: 106 patients ingested the patency capsule. 59 (56%) excreted it intact and subsequently underwent CE. There were no cases of retention of the video capsule. No patency capsules were found to have dissolved before 30 hours after ingestion. Significant findings on CE were found in 24 (41%). There were three adverse events labeled as severe. Two patients had abdominal pain which was also present before entering the study. One patient had nausea. Conclusion: These results suggest that the agile patency system is a useful tool for physicians to use prior to CE in patients with small bowel strictures to avoid retention of the capsule. In those patients believed to be at high risk for obstruction, the patency capsule functioned safely. This group of patients may have a high yield of clinically significant findings at CE. This capsule may determine if patients who have a contraindication to CE may safely undergo CE and obtain useful diagnostic information.
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