Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05318495
Status:
UNKNOWN
Last Update Posted:
2022-04-08
First Post:
2022-03-29
Brief Title:
A Dual Tandem Study - SC vs CAD-EYE vs CAD-EYE With G-EYE
Sponsor:
Dr Horst Schmidt Klinik GmbH
Organization:
Dr Horst Schmidt Klinik GmbH
Study Overview
Official Title:
A Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of SC to That of Artificial Intelligence CAD-EYE Aided Colonoscopy and to That of Artificial Intelligence CAD-EYE and G-EYE Aided Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single-center four-arm dual-tandem randomized open-label study involving the following devices
1 The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging BLI and linked color imaging LCI
2 CAD-EYE is an artificial intelligence software used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas
3 The G-EYE balloon is a reusable reprocessable balloon permanently installed on the distal tip of a standard colonoscope and is also intended to assist in flattening colonic folds and control the colonoscopes field of view and tip positioning
1 The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging BLI and linked color imaging LCI
2 CAD-EYE is an artificial intelligence software used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas
3 The G-EYE balloon is a reusable reprocessable balloon permanently installed on the distal tip of a standard colonoscope and is also intended to assist in flattening colonic folds and control the colonoscopes field of view and tip positioning
Detailed Description:
Single-center four-arm dual-tandem randomized open-label study involving the following devices
1 The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging BLI and linked color imaging LCI
2 CAD-EYE is an artificial intelligence software used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas
3 The G-EYE balloon is a reusable reprocessable balloon permanently installed on the distal tip of a standard colonoscope and is also intended to assist in flattening colonic folds and control the colonoscopes field of view and tip positioning
Total of up to 372 patients will be randomized186 to each of the two tandems
1 The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging BLI and linked color imaging LCI
2 CAD-EYE is an artificial intelligence software used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas
3 The G-EYE balloon is a reusable reprocessable balloon permanently installed on the distal tip of a standard colonoscope and is also intended to assist in flattening colonic folds and control the colonoscopes field of view and tip positioning
Total of up to 372 patients will be randomized186 to each of the two tandems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None