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

Medtronic

Status

Active, not recruiting

Conditions

Small Intestine Disease

Small Intestinal Ulcer Bleeding

Small Intestine Adenocarcinoma

Small Intestine Cancer

Small Intestine Obstruction

Small Intestine Polyp

Study type

Observational

Funder types

Industry

Identifiers

NCT03771508

MDT18014

Details and patient eligibility

About

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

Full 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.

Enrollment

8,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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