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Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed).

Melanie Crystal

A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

A prospective, multicenter, post-market, minimal risk, observational study designed to collect up to 60 PillCamTM SB3 CE procedures and subsequent DAE procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in up to 6 medical centers in the United States (US). The data will be collected from subjects who underwent standard of care (SOC) PillCamTM SB3 CE procedure and were referred to a subsequent SOC DAE. In addition, relevant surgical, endoscopic and histology reports as well as radiological data (such as CT, Magnetic Resonance Enterography (MRE) images and reports) may be collected retrospectively 6 months prior to enrollment and prospectively 3 months post enrollment, when applicable. In addition, up to 400 PillCamTM SB3 CE procedures data may be collected from subjects who underwent SB3 procedure (not necessarily followed by DAE) and abnormal SB findings were indicated in their CE report. Study duration is up to 3 years from initial Institutional Review Board (IRB) approval.

Collected data will include PillCamTM raw data, videos and reports, as well as DAE reports, videos and histology reports (when applicable). Demographic data will also be collected to provide a description of the study population characteristics and disposition. All the collected data will be de-identified by delegated and authorized sites' team members, in a manner that is untraceable by the sponsor. The data will be used by Medtronic Gastrointestinal research and development (R\&D) team in collaboration with third parties, including but not limited to external physicians and R\&D partners, as applicable, for development of an Artificial Intelligence (AI) software system to apply to endoscopy procedures, as well as for SB pathologies detection development and validation.

Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

Prospective Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Procedures Data for Development of an Artificial Intelligence Software System to Apply to Endoscopy Procedures (GPS Study)

Collection of GI pathologies data along with descriptive demographics data for research and development purposes.

Medtronic - MITG

Subjects with normal/abnormal PillCam SB3 procedure

Gemachu Rabu

Amber Eruchalu

Patty Fields

Charles Bluhm, MD

Jeanette Morales

Naveen Gara

Monailsa Nzenwa

Robert Moghimi

Jennifer Nikolich

David Hass

Jacob Wolfer

Mark Fleisher, MD

Stephany Moreno

Alexander Veloso, MD

Michael Mijares

Jodie Barkin

Kurt Rivera

Michael Galambox

Ainyae Holmes

Ali Amir

Candace Parks

Jessica Stotler

Rudrajit Rai

Kristina Agel

Todd Heller, MD

Anne Foley

David Cave, M.D

Laura Lezovich

Jennifer Gamble

Phillip Goldmeier

Marianne Tow

Steve Fern, MD

Corey Schurman

Thomas Attard, MD

Jennifer Colombo, MD

Stephanie Blash

Razvan Arsenescu, MD

Mary Alexander

Jennifer Northrop

Alyssa Erber

Jonathan Erber, MD

Jillian Charyn

Samuel Bitton, MD

Salitah Qureshi

Steven Naymagon

Wendy Brock

Gerard Isenberg

Soliman Adam

Madalina Butnariu, MD

Heather LoMonaco

Kenneth Seres, M.D

Stacy Gerhart

Yasmeen Benamar

Nirav Shah

Michael Matthews

David Kastenberg, MD

Amy Palmisciano

Rich Harlan

Dennis Paige

Brett Van Leer Greenberg

Heather Atkinson

Harish Gagneja

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

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.

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

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

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

Study title	NCT ID	Conditions	Eligibility	Organization
Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)	NCT05450393	Small Intestine... Small Intestine... Small Intestina... Small Intestine... Small Intestine... Small Intestine...	18 Years -	Medtronic - MITG
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)	NCT03771508	Small Intestine... Small Intestine... Small Intestina... Small Intestine... Small Intestine... Small Intestine...	-	Medtronic - MITG
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)	NCT03771508	Small Intestine... Small Intestine... Small Intestina... Small Intestine... Small Intestine... Small Intestine...	-	Medtronic - MITG

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