Indications for Use

  • The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.
  • It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.
  • In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Contraindications

  • Patients with known or suspected GI obstruction, strictures or fistulas based on the clinical picture or pre-procedure testing and profile.
  • Patients with cardiac pacemakers or other implanted electro-medical devices.
  • Patients with swallowing disorders.
  • In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use.

Procedure Risk Information

  • The risks of PillCam™ COLON 2 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™ COLON 2 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™ COLON 2 capsule and until it is excreted, the patient 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.