Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy.
BACKGROUND
Capsule endoscopy (CE) of the small bowel has become a standard diagnostic tool, but there have been concerns regarding the risk of capsule retention in certain high-risk groups. The Agile patency system, 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 for capsule retention.


OBJECTIVE
Our purpose was to assess the ability of the device to help physicians identify which patients with known strictures may safely undergo CE.


METHODS
Patients with known strictures ingested the new patency capsule and underwent periodic scanning until it 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 standard CE was performed.


METHODS
International multicenter study.


METHODS
A total of 106 patients with known strictures.


METHODS
Agile patency system.


METHODS
Performance and safety of Agile patency system.


RESULTS
A total of 106 patients ingested the patency capsule. Fifty-nine (56%) excreted it intact and subsequently underwent CE. There were no cases of capsule retention. Significant findings on CE were found in 24 (41%). There were 3 severe adverse events.


CONCLUSIONS
These results suggest that the Agile patency system is a useful tool for physicians to use before CE in patients with strictures to avoid retention. This group of patients may have a high yield of clinically significant findings at CE. This capsule may determine whether patients who have a contraindication to CE may safely undergo CE and obtain useful diagnostic information.
Herrerias
Juan M
JM
Hospital Virgen de la Macarena, Seville, Spain.
Leighton
Jonathan A
JA
Costamagna
Guido
G
Infantolino
Anthony
A
Eliakim
Rami
R
Fischer
Doron
D
Rubin
David T
DT
Manten
Howard D
HD
Scapa
Eitan
E
Morgan
Douglas R
DR
Bergwerk
Ari J
AJ
Koslowsky
Binyamin
B
Adler
Samuel N
SN
D000293:Adolescent; D000328:Adult; D000368:Aged; D053705:Capsule Endoscopes / Q000009:adverse effects*; D053704:Capsule Endoscopy / Q000009:adverse effects*; D002214:Capsules / Q000592:standards*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology / Q000517:prevention & control*; D007421:Intestine, Small; D008297:Male; D008403:Mass Screening / Q000295:instrumentation; D008875:Middle Aged; D012307:Risk Factors
D002214:Capsules