An observational study in Small Intestine Disease, Small Intestine Cancer and Small Intestinal Ulcer Bleeding, sponsored by Medtronic - MITG. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Medtronic - MITG · Observational
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).
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.
177 studies on the registry are indexed under Intestinal Neoplasms; 20 are open to participants now.
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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).
Exclusion Criteria:
Subjects with abnormal PillCam SB3 procedure followed by DAE (if performed).
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.
Time frame: Up to 3 years from study approval
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG