The PillCam Platform with PillCam SB capsules is intended for visualization of the small bowel mucosa and:
- May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy
- May be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy
- May be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy
The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
- Patients with known or suspected GI obstructions, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile
- Patients with cardiac pacemakers or other implanted electromedical devices
- Patients with swallowing disorders
Capsule retention has been reported in less than two percent of all small bowel capsule endoscopy procedures. Capsule retention is defined as having a capsule that remains in the digestive tract for more than two weeks.
Causes of retention cited in the literature include: NSAID strictures, Crohn’s disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis. Summaries in published literature identify the risk of retention for obscure bleeding to be 1.5%; for suspected Crohn’s disease to be 1.4%; for known Crohn’s disease the risk is higher at 5%; and for neoplastic lesions, the rate of retention is 2.1%; as compared to healthy volunteers (Cave et al, 2005; Liao et al, 2010). To verify passage of the capsule from the GI tract, an abdominal X-ray may be obtained at the discretion of the physician.
There is a rare risk of capsule aspiration while patients are attempting to swallow a PillCam capsule. There is also a low risk of skin irritation from the PillCam sensor array’s sleeve adhesive or silicone exposure.
The PillCam capsule may be administered by using transendoscopic delivery in patients who are either unable to ingest the capsule or who are known to have slow gastric emptying. If using transendoscopic delivery, potential complications include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, and cardiac arrhythmia or arrest.
Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
After ingesting a PillCam capsule and until the capsule is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device.
This information should not be used as a substitute for medical advice concerning specific diagnosis and treatment.
1. Cave et al. Endoscopy 2005; 37: 1065-1067.
2. Liao et al. GI Endoscopy 2010; 71: 280-286.