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

Small Intestine Cancer Clinical Trial

— SODA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771508
• Other study ID #: MDT18014
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Medtronic - MITG
• Contact: Gemachu Rabu
• Phone: 1.774.245.8756
• Email: gemachu.rabu[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Intestinal Neoplasms
• Intestinal Obstruction
• Small Intestinal Ulcer Bleeding
• Small Intestine Adenocarcinoma
• Small Intestine Cancer
• Small Intestine Disease
• Small Intestine Obstruction
• Small Intestine Polyp

Locations

Country	Name	City	State
United States	Albany Gastroenterology Consultants	Albany	New York
United States	Digestive Healthcare of GA	Atlanta	Georgia
United States	Austin Gastro	Austin	Texas
United States	Birmingham Gastroenterology Associates	Birmingham	Alabama
United States	Erber M.D. PC	Brooklyn	New York
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Capital Digestive Care	Chevy Chase	Maryland
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Gastro Center of Maryland	Columbia	Maryland
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Gastroenterology & Liver Institute	Escondido	California
United States	USDH Clinical Research	Exton	Pennsylvania
United States	Digestive Health Associates	Farmington Hills	Michigan
United States	Medical Research Center of Connecticut	Hamden	Connecticut
United States	Encore Borland-Groover	Jacksonville	Florida
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Northwell Health - Cohen Children's Medical Center of New York	Lake Success	New York
United States	Research Associates of South Florida	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Atlantic Digestive Health Institute	Morristown	New Jersey
United States	New York Gastroenterology Associates	New York	New York
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Woodholme Gastroenterology Associates	Pikesville	Maryland
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Palmetto Primary Care	Summerville	South Carolina
United States	The Toledo Clinic	Toledo	Ohio
United States	Amicis Research Center	Valencia	California
United States	UMass Memorial Health Care	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective collection of PillCam SB3 videos	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	Up to 7 years from study approval