Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)

Study Overview
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Brief Summary
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Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam SB3 videos (including PillCam reports) and raw data files and optional collection of Eneteroscopy reports

Detailed Description
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Up to 8000 PillCam SB3 videos (including PillCam reports) and raw data files will be collected in up to 50 medical centers in the US. Study duration is up to 7 years from IRB approval. Medical center study sites will provide relevant videos (including PillCam reports) and raw data from patients who underwent SB3 procedures. Per patient demographic data will be also collected to provide a description of the study population characteristics and disposition. Additional Standard of care data collection might be performed (optional). This data will include a de-identified Eneteroscopy report, from patients enrolled to the study and referred to Eneteroscopy procedure (all types of Eneteroscopies), following findings identified during the PillCamTM SB procedure, as part of the standard of care procedure. This data might be collected retrospectively for enrolled patients who underwent an Eneteroscopy procedure. The de-identified reports will be used by MDT GI research and development team to further develop and validated SB capsule localization. Study subjects will not undergo any additional procedures, nor will their diagnosis and subsequent treatment pathway be changed for the purpose of the registry. The data will be used by MDT GIs research and development team for the development and validation of improved and new detectors in the PillCam software. The videos (including PillCam reports) and raw data files will be de-identified at the medical center by representatives who are authorized and delegated to review medical records, prior to providing them to the sponsor. All data in the study- videos, reports, raw data files and demographic information will be de-identified in a manner that is untraceable by the sponsor clinical study team members.

Official Title
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PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection

Conditions
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Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding, Small Intestine Obstruction, Small Intestine Adenocarcinoma, Small Intestine Polyp

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All SB3 cases collected during standard of care procedures. The subject received an explanation and understands the nature of the study and provided oral consenting Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PillCam SB3 procedure<br>Subjects with normal/abnormal PillCam SB3 procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective collection of PillCam SB3 videos | sponsor database will be expanded with images of pathologies and normal mucosa for future development and validation of improved algorithms for GI pathologies detection with the PillCam platform | Up to 7 years from study approval |