Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Small Intestinal Ulcer Bleeding
- Small Intestine Adenocarcinoma
- Small Intestine Cancer
- Small Intestine Disease
- Small Intestine Obstruction
- Small Intestine Polyp
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Up to 5000 PillCam SB3 videos (including PillCam reports) and raw data files will be collected in up to 25 medical centers in the US. Study duration is up to 3 years from IRB approval. Medical center study sites will provide relevant videos (including PillCam reports) and raw data from patients who ...
Up to 5000 PillCam SB3 videos (including PillCam reports) and raw data files will be collected in up to 25 medical centers in the US. Study duration is up to 3 years from IRB approval. Medical center study sites will provide relevant videos (including PillCam reports) and raw data from patients who underwent SB3 procedures. 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. Videos, reports and raw data files will be de-identified in a manner that is untraceable by the sponsor clinical study team members.
Tracking Information
- NCT #
- NCT03771508
- Collaborators
- Not Provided
- Investigators
- Not Provided
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