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A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

Primary Purpose

Adenoma, Colo-rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Standard Colonoscopy
CAD-EYE
G-EYE
Sponsored by
Dr. Horst Schmidt Klinik GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adenoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Screening and surveillance population for Adenoma and CRC.
  2. The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria:

  1. Subjects with inflammatory bowel disease;
  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

Sites / Locations

  • Helios Dr. Horst Schmidt KlinikenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy

Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE

Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy

Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE

Arm Description

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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).

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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).

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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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 colonoscope's field of view and tip positioning.

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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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 colonoscope's field of view and tip positioning.

Outcomes

Primary Outcome Measures

Additional adenoma detection yield
additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
April 7, 2022
Sponsor
Dr. Horst Schmidt Klinik GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05318495
Brief Title
A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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. 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 colonoscope's field of view and tip positioning.
Detailed Description
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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. 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 colonoscope's field of view and tip positioning. Total of up to 372 patients will be randomized,186 to each of the two tandems

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colo-rectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy
Arm Type
Experimental
Arm Description
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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Arm Title
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE
Arm Type
Active Comparator
Arm Description
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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Arm Title
Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy
Arm Type
Experimental
Arm Description
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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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 colonoscope's field of view and tip positioning.
Arm Title
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE
Arm Type
Active Comparator
Arm Description
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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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 colonoscope's field of view and tip positioning.
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Intervention Type
Device
Intervention Name(s)
CAD-EYE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
G-EYE
Intervention Description
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 colonoscope's field of view and tip positioning.
Primary Outcome Measure Information:
Title
Additional adenoma detection yield
Description
additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Screening and surveillance population for Adenoma and CRC. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: Subjects with inflammatory bowel disease; Subjects with a personal history of hereditary polyposis syndrome; Subjects with suspected chronic stricture potentially precluding complete colonoscopy; Subjects with diverticulitis or toxic megacolon; Subjects with prior colonic surgery (exclusion appendectomy) Subjects with a history of radiation therapy to abdomen or pelvis; Pregnant or lactating female subjects; Subjects who are currently enrolled in another clinical investigation. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) Any patient condition deemed too risky for the study by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf Kiesslich, Prof.
Phone
49-611432421
Email
Ralf.Kiesslich@helios-gesundheit.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof.
Organizational Affiliation
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Dr. Horst Schmidt Kliniken
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof.
Phone
49-611432421
Email
ralf.kiesslich@helios-gesundheit.de

12. IPD Sharing Statement

Learn more about this trial

A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

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