Small Intestine DiseaseSODANCT03771508
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
An observational study of Small Intestine Disease and Small Intestine Cancer, run by Medtronic - MITG at 30 sites in United States.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding
- How many people
- 3,712 participants
- Where
- 30 sitesUnited States
- Study dates
- 13 Dec 2018to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent Standard of Care SB3 procedure
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Albany Gastroenterology Consultants
Albany, New York, 12206
Digestive Healthcare of GA
Atlanta, Georgia, 30309
Austin Gastro
Austin, Texas, 78757
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209
Erber M.D. PC
Brooklyn, New York, 11218
Clinical Research Professionals
Chesterfield, Missouri, 63005
Capital Digestive Care
Chevy Chase, Maryland, 20815
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
Gastro Center of Maryland
Columbia, Maryland, 21045
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Gastroenterology & Liver Institute
Escondido, California, 92025
USDH Clinical Research
Exton, Pennsylvania, 19431
Digestive Health Associates
Farmington Hills, Michigan, 48334
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Encore Borland-Groover
Jacksonville, Florida, 32256
The University of Kansas Medical Center
Kansas City, Kansas, 66160
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Northwell Health - Cohen Children's Medical Center of New York
Lake Success, New York, 11042
Research Associates of South Florida
Miami, Florida, 33134
University of Miami Miller School of Medicine
Miami, Florida, 33136-1060
Atlantic Digestive Health Institute
Morristown, New Jersey, 07960
New York Gastroenterology Associates
New York, New York, 10128
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Woodholme Gastroenterology Associates
Pikesville, Maryland, 21209
Rhode Island Hospital
Providence, Rhode Island, 02903
Palmetto Primary Care
Summerville, South Carolina, 29486
The Toledo Clinic
Toledo, Ohio, 43623
Amicis Research Center
Valencia, California, 91355
UMass Memorial Health Care
Worcester, Massachusetts, 01655
About this study
Official title: PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PillCam SB3 procedure | Subjects with normal/abnormal PillCam SB3 procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 years from study approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start13 Dec 2018
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Sojourner, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771508
- Sponsor's protocol ID
- MDT18014
- Acronym
- SODA
- Status last verified
- Jul 2025
- First submitted
- 7 Dec 2018
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection
- ClinicalTrials.gov ID
- NCT03771508
- Acronym / sponsor ID
- SODA / MDT18014
- Conditions
- Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding, Small Intestine Obstruction, Small Intestine Adenocarcinoma, Small Intestine Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,712 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillCam SB3 procedure | – | –Subjects with normal/abnormal PillCam SB3 procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent Standard of Care SB3 procedure
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospective collection of PillCam SB3 videos
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: No. Patient data will not be shared.
Related trials for Small Intestine Disease
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Sojourner study director
Medtronic
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestine Disease and Small Intestine Cancer, run by Medtronic - MITG at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective collection of PillCam SB3 videos (time frame: Up to 7 years from study approval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.