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

Sponsor
Medtronic - MITG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03771508
Collaborator
(none)
8,000
Enrollment
16
Locations
84.6
Anticipated Duration (Months)
500
Patients Per Site
5.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 13, 2018
    Anticipated Primary Completion Date :
    Dec 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    PillCam SB3 procedure

    Subjects with normal/abnormal PillCam SB3 procedure

    Outcome Measures

    Primary Outcome Measures

    1. Prospective collection of PillCam SB3 videos [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Gastroenterology Associates Birmingham Alabama United States 35209
    2 Medical Research Center of Connecticut Hamden Connecticut United States 06518
    3 Encore Borland-Groover Jacksonville Florida United States 32256
    4 Research Associates of South Florida Miami Florida United States 33134
    5 Digestive Healthcare of GA Atlanta Georgia United States 30309
    6 The University of Kansas Medical Center Kansas City Kansas United States 66160
    7 Gastro Center of Maryland Columbia Maryland United States 21045
    8 UMass Memorial Health Care Worcester Massachusetts United States 01655
    9 Clinical Research Professionals Chesterfield Missouri United States 63005
    10 Atlantic Digestive Health Institute Morristown New Jersey United States 07960
    11 Erber M.D. PC Brooklyn New York United States 11218
    12 Northwell Health - Cohen Children's Medical Center of New York Lake Success New York United States 11042
    13 New York Gastroenterology Associates New York New York United States 10128
    14 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    15 Digestive Disease Specialists Inc Oklahoma City Oklahoma United States 73112
    16 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Medtronic - MITG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic - MITG
    ClinicalTrials.gov Identifier:
    NCT03771508
    Other Study ID Numbers:
    • MDT18014
    First Posted:
    Dec 11, 2018
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Intestinal Neoplasms
    Intestinal Diseases
    Intestinal Obstruction

    Study Results

    No Results Posted as of Aug 17, 2022