Small Intestine DiseaseNCT05450393
Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)
An observational study of Small Intestine Disease and Small Intestine Cancer, run by Medtronic - MITG.
Trial summary
A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who underwent standard of care (SOC) PillCamTM SB3 CE and subsequent DAE procedures or Subjects who underwent SOC PillCamTM SB3 CE procedures only and abnormal findings were indicated in their CE report (optional).
Who may be able to join
- Adult male and female subjects (≥18 years)
- The subject underwent a SOC PillCamTM SB3 CE procedure and is referred to a subsequent DAE procedure(s), as part of the routine care or The subject underwent a SOC PillCamTM SB3 CE procedure (not necessarily followed by a DAE) and abnormal findings were indicated in the CE report (optional).
- The subject received an explanation and understands the nature of the study and provided oral consent.
Who cannot join
- 1. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
About this study
Official title: Prospective Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Procedures Data for Development of an Artificial Intelligence Software System to Apply to Endoscopy Procedures (GPS Study)
A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).
Read the detailed description
A prospective, multicenter, post-market, minimal risk, observational study designed to collect up to 60 PillCamTM SB3 CE procedures and subsequent DAE procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in up to 6 medical centers in the United States (US). The data will be collected from subjects who underwent standard of care (SOC) PillCamTM SB3 CE procedure and were referred to a subsequent SOC DAE. In addition, relevant surgical, endoscopic and histology reports as well as radiological data (such as CT, Magnetic Resonance Enterography (MRE) images and reports) may be collected retrospectively 6 months prior to enrollment and prospectively 3 months post enrollment, when applicable. In addition, up to 400 PillCamTM SB3 CE procedures data may be collected from subjects who underwent SB3 procedure (not necessarily followed by DAE) and abnormal SB findings were indicated in their CE report. Study duration is up to 3 years from initial Institutional Review Board (IRB) approval.
Collected data will include PillCamTM raw data, videos and reports, as well as DAE reports, videos and histology reports (when applicable). Demographic data will also be collected to provide a description of the study population characteristics and disposition. All the collected data will be de-identified by delegated and authorized sites' team members, in a manner that is untraceable by the sponsor. The data will be used by Medtronic Gastrointestinal research and development (R\&D) team in collaboration with third parties, including but not limited to external physicians and R\&D partners, as applicable, for development of an Artificial Intelligence (AI) software system to apply to endoscopy procedures, as well as for SB pathologies detection development and validation.
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 SB procedure and deep enteroscopy (Device-assisted enteroscopy, DAE) | Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective collection of PillCamTM SB3 capsule endoscopy and DAE procedures data
Collection of GI pathologies data along with descriptive demographics data for research and development purposes.
Measured: Up to 3 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 posted8 Jul 2022
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Why it stopped: Study was cancelled by sponsor due to priority realignment
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450393
- Sponsor's protocol ID
- MDT21042
- Status last verified
- Oct 2023
- First submitted
- 28 Jun 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Procedures Data for Development of an Artificial Intelligence Software System to Apply to Endoscopy Procedures (GPS Study)
- ClinicalTrials.gov ID
- NCT05450393
- Acronym / sponsor ID
- MDT21042
- 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
- WithdrawnReason stopped: Study was cancelled by sponsor due to priority realignment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Jul 2022 (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.
A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).
Detailed description
A prospective, multicenter, post-market, minimal risk, observational study designed to collect up to 60 PillCamTM SB3 CE procedures and subsequent DAE procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in up to 6 medical centers in the United States (US). The data will be collected from subjects who underwent standard of care (SOC) PillCamTM SB3 CE procedure and were referred to a subsequent SOC DAE. In addition, relevant surgical, endoscopic and histology reports as well as radiological data (such as CT, Magnetic Resonance Enterography (MRE) images and reports) may be collected retrospectively 6 months prior to enrollment and prospectively 3 months post enrollment, when applicable. In addition, up to 400 PillCamTM SB3 CE procedures data may be collected from subjects who underwent SB3 procedure (not necessarily followed by DAE) and abnormal SB findings were indicated in their CE report. Study duration is up to 3 years from initial Institutional Review Board (IRB) approval.
Collected data will include PillCamTM raw data, videos and reports, as well as DAE reports, videos and histology reports (when applicable). Demographic data will also be collected to provide a description of the study population characteristics and disposition. All the collected data will be de-identified by delegated and authorized sites' team members, in a manner that is untraceable by the sponsor. The data will be used by Medtronic Gastrointestinal research and development (R\&D) team in collaboration with third parties, including but not limited to external physicians and R\&D partners, as applicable, for development of an Artificial Intelligence (AI) software system to apply to endoscopy procedures, as well as for SB pathologies detection development and validation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillCam SB procedure and deep enteroscopy (Device-assisted enteroscopy, DAE) | – | –Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who underwent standard of care (SOC) PillCamTM SB3 CE and subsequent DAE procedures or Subjects who underwent SOC PillCamTM SB3 CE procedures only and abnormal findings were indicated in their CE report (optional).
Key inclusion criteria (3 listed)
- Adult male and female subjects (≥18 years)
- The subject underwent a SOC PillCamTM SB3 CE procedure and is referred to a subsequent DAE procedure(s), as part of the routine care or The subject underwent a SOC PillCamTM SB3 CE procedure (not necessarily followed by a DAE) and abnormal findings were indicated in the CE report (optional).
- The subject received an explanation and understands the nature of the study and provided oral consent.
Key exclusion criteria (1 listed)
- 1. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
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 PillCamTM SB3 capsule endoscopy and DAE procedures data
Time frame: Up to 3 years from study approval
Collection of GI pathologies data along with descriptive demographics data for research and development purposes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.
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 3 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: withdrawn, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 PillCamTM SB3 capsule endoscopy and DAE procedures data (time frame: Up to 3 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 19 Aug 2024.