User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 22 of 90
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9. Give the subject the required materials (contrast material and fiber pills) for the
procedure.
10. Verify that the subject has the Subject IFU and understands the requirements.
11. Release the subject home.
6.3 During the procedure days (from C-Scan
®
Cap ingestion to excretion)
 Subject continues normal life routine during the procedure days.
Note: In case the subject feels unwell consider inviting him for a medical check.
 After capsule excretion subject shall contact the clinic team to inform that the capsule
was excreted and send the C-Scan
®
Track and Cap for analysis using the dedicated
package received at the ingestion procedure.
 In case the C-Scan
®
Cap is not excreted after more than 100 hours from ingestion,
the clinical team shall:
1. Instruct the subject to stop taking fiber supplements and contrast agent.
Note: Instruct the subject to not remove the C-Scan
®
Track from the back at this
point.
2. Prescribe abdominal X-Ray to verify the location of the C-Scan
®
Cap within the
GI system.
3. Evaluate the subject for obstruction symptoms.
4. In case Capsule is still in the colon and the subject feels well and shows no
obstruction symptoms, continue to monitor for symptoms of obstruction and for
excretion of the capsule for additional 50 hours.
During the same time, instruct the subject to start colonoscopy preparation
followed by a colonoscopy procedure for Capsule retrieving. If symptoms of
obstruction occur, instruct the subject to stop the bowel preparation immediately
and contact the clinical team.
5. In case Capsule is still in the colon and there are signs of bowel obstruction,
surgical retrieval of the capsule may be required. Instruct the subject not to take
any laxatives or fiber supplements. Proceed with the safest and best clinical
practice, which may include radiologic imaging such as CT abdomen and pelvis
or hypaque enema, or endoscopic retrieval e.g. if capsule is located in the recto-
sigmoid colon when an enema may be administered.
6. In case there are no obstruction symptoms, and the Capsule is located in the
upper GI tract, an endoscopic procedure for retrieving the Capsule will be
performed.
7. In case there are obstruction symptoms, or the Capsule is in an unreachable
position for both endoscopy and colonoscopy, or if the subject cannot tolerate the
bowel preparation due to worsening symptoms, a surgical procedure for Capsule
retrieval may be performed. In such a case, prior to the surgical procedure, the
physician may consider an abdomen CT scan to evaluate the Capsule's location
and exclude other causes for symptoms.