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
1320 participants
INTERVENTIONAL
2021-11-08
2022-06-30
Brief Summary
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Detailed Description
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Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):
Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery \& G-EYE® aided colonoscopy.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Standard Colonoscopy
Subjects will undergo colonoscopy using a standard colonoscope
Standard Colonoscopy
In this arm, subjects will undergo colonoscopy using a standard colonoscope
Discovery aided colonoscopy
Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy
Discovery aided colonoscopy
the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
Discovery and G-EYE aided colonoscopy
Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy
Discovery and G-EYE
The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery
Interventions
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Standard Colonoscopy
In this arm, subjects will undergo colonoscopy using a standard colonoscope
Discovery aided colonoscopy
the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
Discovery and G-EYE
The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery
Eligibility Criteria
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Inclusion Criteria
2. The patient must understand and sign a written informed consent for the procedure.
Exclusion Criteria
2. Subjects with a personal history of hereditary polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with prior colonic surgery (exclusion appendectomy)
6. Subjects with a history of radiation therapy to abdomen or pelvis;
7. Pregnant or lactating female subjects;
8. Subjects who are currently enrolled in another clinical investigation.
9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
11. Any patient condition deemed too risky for the study by the investigator
ALL
Yes
Sponsors
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Dr. Horst Schmidt Klinik GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ralf Kiesslich, Prof.
Role: PRINCIPAL_INVESTIGATOR
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Locations
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Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Wiesbaden, , Germany
Countries
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Central Contacts
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Facility Contacts
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Ralf Kiesslich, Prof.
Role: primary
Other Identifiers
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G-EYE/Discovery
Identifier Type: -
Identifier Source: org_study_id