Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA) (SODA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03771508|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 31, 2023
|Condition or disease|
|Small Intestine Disease Small Intestine Cancer Small Intestinal Ulcer Bleeding Small Intestine Obstruction Small Intestine Adenocarcinoma Small Intestine Polyp|
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.
|Study Type :||Observational|
|Estimated Enrollment :||8000 participants|
|Official Title:||PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection|
|Actual Study Start Date :||December 13, 2018|
|Estimated Primary Completion Date :||December 30, 2025|
|Estimated Study Completion Date :||December 30, 2025|
PillCam SB3 procedure
Subjects with normal/abnormal PillCam SB3 procedure
- Prospective collection of PillCam SB3 videos [ Time Frame: Up to 7 years from study approval ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771508
|Contact: Roslana Foxfirstname.lastname@example.org|
|Contact: Zina Goldbaumemail@example.com|