Indications For Use; Device Description - CapsoVision CapsoCamPlus Instrucciones De Uso

Indications for Use

The CapsoCam Plus® capsule system is intended for
visualization of the small bowel mucosa in patients ages
2 and above. It may be used as a tool in the detection of
abnormalities of the small bowel.
Indications for Pediatric Use
Based upon review of the published literature and available
guidelines published to date, indications for Capsule
Endoscopy (CE) in pediatric patients are as follows:
• Diagnosis of Inflammatory Bowel Disease (IBD), including
the evaluation of suspected Crohn' s Disease (CD) and the
ongoing diagnostic surveillance of pediatric patients
with established CD.
• A normal CE study has a high specificity for excluding
small bowel CD.
• CE should be recommended in suspected cases of CD when
conventional endoscopy and imaging tools are not feasible
or have been non-diagnostic and no bowel obstructive
symptoms are present.
• The possibility of capsule retention should be carefully
considered in patients at risk for intestinal stenosis, mainly
those with a previous abdominal surgery and those with
suspected or established Crohn' s disease.
• Diagnosis of Occult Gastrointestinal Bleeding (OGIB) and/or
Chronic Anemia—as an alternative diagnostic
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Document Number: IFU-2320 Rev: J Revision Date: 08/2020
methodology and as a tool for management of OGIB in
pediatric patients.
• Diagnosis of Polyposis Syndromes—providing safe,
accurate detection of small-bowel polyps in pediatric
patients. Specifically, CE may be a useful tool in the
screening and surveillance of patients with Peutz-Jeghers
syndrome (PJS).
• CE may be useful as an alternative diagnostic modality
for other diseases affecting the pediatric population such as:
celiac disease and malabsorption syndrome,
lymphangiectasia, graft-versus-host disease, chronic
abdominal pain, and failure to thrive.

Device Description

CapsoCam Plus is a single-use, ingestible capsule that acquires
and stores endoscopy examination images in onboard memory
while moving through the gastrointestinal tract, propelled by
natural peristalsis. The patient retrieves the capsule using the
provided retrieval kit and returns it to the physician (or mails
the capsule to the download center in a pre-paid envelope)
where the capsule is processed and data is downloaded. The
images can be reviewed on a computer or tablet (select
countries only). The capsule is typically excreted within 3 to 30
hours after being swallowed.
CapsoCam Plus Accessories
• CapsoRetrieve Retrieval Kit: intended to collect the
excreted CapsoCam Plus capsule.