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Trial record 1 of 1 for:    MDT18014
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Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA) (SODA)

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ClinicalTrials.gov Identifier: NCT03771508
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
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

Condition or disease
Small Intestine Disease Small Intestine Cancer Small Intestinal Ulcer Bleeding Small Intestine Obstruction Small Intestine Adenocarcinoma Small Intestine Polyp

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Group/Cohort
PillCam SB3 procedure
Subjects with normal/abnormal PillCam SB3 procedure



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent Standard of Care SB3 procedure
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Roslana Fox 972-542355303 roslana.fox@medtronic.com
Contact: Zina Goldbaum zina.goldbaum@medtronic.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Medtronic - MITG
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03771508    
Other Study ID Numbers: MDT18014
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Intestinal Neoplasms
Intestinal Diseases
Intestinal Obstruction
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases