CapsoVision CapsoCamPlus Instrucciones De Uso página 5

according to these instructions for use and hospital
procedures, but the probability of occurrence is very low.
• Summaries in published literature identify the risk of
capsule retention to be approximately 1.5% for obscure
bleeding, 1.4% for suspected Crohn' s disease, 5% for
known Crohn' s , and 2.1% for neoplastic lesions. [1], [2].
[1] Cave et al. Endoscopy. 2005; 37: 1065-1067.
[2] Zhuan et al. GI Endoscopy. 2010; 71: 280-286
Special Considerations for Pediatrics
• Consideration should be given to the risk versus benefit of
performing a small bowel series in pediatric patients to
evaluate the presence or absence of strictures or fistulas in
the small bowel of pediatric patients since the risk of the
potentially detrimental effect of radiation may be greater to
the pediatric patient and the diagnostic accuracy of this
procedure may not effectively exclude the potential of
capsule retention. Magnetic Resonance Endoscopy (MRE) or
the administration of a Patency Capsule should be
considered as possible diagnostic modalities to evaluate the
potential presence of strictures or fistulas and the potential
risk of capsule retention.
• Consideration should be given to the risk versus benefit of
utilizing a commercially available patency capsule for
evaluation of small bowel patency for CapsoCam Plus
capsule (30.5mm x 11.3mm) in pediatric patients. While
patency capsules are useful tools for evaluating small bowel
Document Number: IFU-2320 Rev: J Revision Date: 08/2020
patency, they do not always fully characterize the presence of
possible strictures in the small bowel. Patency capsules may
also result in additional risk of infection and perforation as
they may be retained in the small bowel. The manufacturer' s
recommendations regarding pediatric use of commercially
available patency capsules should be consulted.
• Consideration should be given to the risk versus benefit of
using CE in pediatric patients as the initial diagnostic
modality for evaluation of suspected OGIB and/or chronic
anemia because there are no clinical evaluations specifically
addressing the indication or performance of CE in children
with OGIB. Clinical guidelines published to-date suggest
that gastroscopy or colonoscopy be utilized as initial
diagnostic modalities in pediatric patients suspected or
documented to have OGIB and/or chronic anemia. CE may
be effective as a diagnostic modality for use when other
methods have failed to document causation of OGIB and/or
chronic anemia.
• Consideration should be given to the risk versus benefit
of using CE in pediatric patients in various states of
malnutrition as there are some limited data from a single
source suggesting that pediatric patients with lower BMI
may be at increased risk of capsule retention.
• Complications of CE in the pediatric patient, while seldom
seen based upon review of published guidelines, are similar
to those in adult patients, with capsule retention being the
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