Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.
NCT ID: NCT04909671
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
404 participants
INTERVENTIONAL
2021-09-13
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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CAD arm
Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)
Gi Genius, Medtronic
GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.
WLE arm
Patients allocated to WLE arm will receive during colonoscopy withdrawal high definition white light endoscopy as standart of care.
White light standart colonoscopy
High definition white light endoscopy will be used during the scope withdrawal
Interventions
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Gi Genius, Medtronic
GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.
White light standart colonoscopy
High definition white light endoscopy will be used during the scope withdrawal
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant inflammatory bowel disease,
* Inability or refuse to sign the informed consent,
* Previous colonoscopy \< 12 months.
* Inadequate bowel preparation.
* Incomplete procedure.
* PMS2 mutation carriers
18 Years
ALL
No
Sponsors
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European Society of Gastrointestinal Endoscopy
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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María Pellisé
Principal Investigator. Attending physician Gastroenterology department.
Locations
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María Pellisé. MD. PhD.
Barcelona, , Spain
Oswaldo ortiz
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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Timely
Identifier Type: -
Identifier Source: org_study_id
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