Clinical trial NCT03771508: Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Official title: PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Small Intestine Disease
Small Intestine Cancer
Small Intestinal Ulcer Bleeding
Small Intestine Obstruction
Small Intestine Adenocarcinoma
Small Intestine Polyp
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent Standard of Care SB3 procedure

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.

Eligibility 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

Primary outcomes:
measure: Prospective collection of PillCam SB3 videos
timeFrame: Up to 7 years from study approval
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates
state: Alabama
city: Escondido
country: United States
facility: Gastroenterology & Liver Institute
state: California
city: Valencia
country: United States
facility: Amicis Research Center
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: Jacksonville
country: United States
facility: Encore Borland-Groover
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of GA
state: Georgia
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Chevy Chase
country: United States
facility: Capital Digestive Care
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Pikesville
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Health Care
state: Massachusetts
city: Farmington Hills
country: United States
facility: Digestive Health Associates
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Morristown
country: United States
facility: Atlantic Digestive Health Institute
state: New Jersey
city: Albany
country: United States
facility: Albany Gastroenterology Consultants
state: New York
city: Brooklyn
country: United States
facility: Erber M.D. PC
state: New York
city: Lake Success
country: United States
facility: Northwell Health - Cohen Children's Medical Center of New York
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Exton
country: United States
facility: USDH Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Summerville
country: United States
facility: Palmetto Primary Care
state: South Carolina
city: Austin
country: United States
facility: Austin Gastro
state: Texas
Study officials:
References: