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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03771508

Acronym

SODA

Enrollment

3712

Registered

2018-12-11

Start date

2018-12-13

Completion date

2025-09-30

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestinal Ulcer Bleeding, Small Intestine Adenocarcinoma, Small Intestine Cancer, Small Intestine Disease, Small Intestine Obstruction, Small Intestine Polyp

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

* None

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results