Comparison of Colonoscopy Adenoma Detection Yield
Primary Purpose
Adenoma Colon
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Standard Colonoscopy
Discovery aided colonoscopy
Discovery and G-EYE
Sponsored by
About this trial
This is an interventional screening trial for Adenoma Colon
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
Sites / Locations
- Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Standard Colonoscopy
Discovery aided colonoscopy
Discovery and G-EYE aided colonoscopy
Arm Description
Subjects will undergo colonoscopy using a standard colonoscope
Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy
Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy
Outcomes
Primary Outcome Measures
Adenoma detection yield
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy
Secondary Outcome Measures
Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)
Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)
Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)
Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy
Full Information
NCT ID
NCT05158725
First Posted
December 2, 2021
Last Updated
December 2, 2021
Sponsor
Dr. Horst Schmidt Klinik GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05158725
Brief Title
Comparison of Colonoscopy Adenoma Detection Yield
Official Title
Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.
Detailed Description
Multi-center, three-arm, randomized, controlled, open-label study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Multi-center, three-arm, randomized, controlled, open-label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Subjects will undergo colonoscopy using a standard colonoscope
Arm Title
Discovery aided colonoscopy
Arm Type
Active Comparator
Arm Description
Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy
Arm Title
Discovery and G-EYE aided colonoscopy
Arm Type
Experimental
Arm Description
Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
In this arm, subjects will undergo colonoscopy using a standard colonoscope
Intervention Type
Device
Intervention Name(s)
Discovery aided colonoscopy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Discovery and G-EYE
Intervention Description
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
Primary Outcome Measure Information:
Title
Adenoma detection yield
Description
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy
Time Frame
Upon histology results (up to 30 days)
Secondary Outcome Measure Information:
Title
Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)
Description
Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Time Frame
Upon histology results (up to 30 days)
Title
Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)
Description
Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Time Frame
Upon histology results (up to 30 days)
Title
Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)
Description
Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy
Time Frame
Upon histology results (up to 30 days)
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
+49 611 43-9002
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 GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
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
+49 611 43-9002
Email
Ralf.Kiesslich@helios-gesundheit.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Colonoscopy Adenoma Detection Yield
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