The PillCam™ Crohn’s capsule is intended for visualization of the small bowel and colonic mucosa:
- It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn’s disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn’s disease
- It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy
- The PillCam™ Crohn’s capsule may be used as a tool in the detection of abnormalities of the small bowel
- It is intended for use in adults
CONTRAINDICATIONS
The PillCam™ Crohn’s capsule is contraindicated for use under the following conditions:
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile
- In patients with cardiac pacemakers or other implanted electromedical devices
- In patients with dysphagia or other swallowing disorders
- In patients with allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use
PROCEDURE RISK INFORMATION
The risks of the PillCam™ Crohn’s capsule include capsule retention, aspiration, and skin irritation. The risks associated with colon preparation are allergies or other known contraindications to any preparation agents or medications used for the PillCam™ Crohn’s system regimen, according to laxative medication labeling and per physician discretion. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. After ingesting the PillCam™ Crohn’s capsule, and until the capsule is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device. Please refer to the product user manual for detailed information.
