This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.
The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa. Fifty established and suspected IBD patients (at least half of them with established crohn disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no symptomatic stricture or known obstruction that would prevent capsule passage will be enrolled in up to 6 medical sites in Israel and Europe. Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency capsule may precede PillCam SBC ingestion according to physician discretion. The PillCam Software videos will be evaluated by local site reader following a Subjective Assessment Form fulfillment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
54
The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
Shaare Zedek Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
The Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
Successful SBC procedure in terms of video creation and report generation per training instructions
Success procedures are being measured. Only if both video and report will be created it will be defined as success.
Time frame: 4 weeks
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Hospital de Navarra
Pamplona, Spain