Back to resultsAccuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy (ACCENDO-Colo)
Primary Purpose
Adenoma Colon, Colonic Adenoma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ENDO-Aid by Olympus
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma Colon focused on measuring ADR, CADe, Endo-AID
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years or ≤85 Patients undergoing screening, follow-up, or diagnostic colonoscopy Exclusion Criteria: Suspected or known inflammatory bowel disease Colonic resection Taking anticoagulants or antiaggregants that contraindicate the performance of therapy Patients with incomplete colonoscopy Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate. Inability to provide informed consent.
Sites / Locations
- Fondazione Poliambulanza
- Policlinico Universitario Agostino Gemelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CADe Colonoscopy
Conventional Colonoscopy
Arm Description
Colonoscopy with the help of CADe system (ENDO-Aid)
Standard Colonoscopy with white light
Outcomes
Primary Outcome Measures
Adenoma detection rate (ADR)
ADR defined as the proportion of patients with at least 1 adenoma detected.
Secondary Outcome Measures
Polyp detection rate (PDR)
PDR defined as the proportion of patients with at least 1 polyp detected.
Polyp per colonoscopy (PPC)
PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Adenoma per colonoscopy (APC)
APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Sessile serrated lesion detection rate (SSLDR)
SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies.
Advanced adenoma detection rate (AADR)
AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)
Full Information
NCT ID
NCT05862948
First Posted
May 4, 2023
Last Updated
May 15, 2023
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
1. Study Identification
Unique Protocol Identification Number
NCT05862948
Brief Title
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
Acronym
ACCENDO-Colo
Official Title
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
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
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon, Colonic Adenoma
Keywords
ADR, CADe, Endo-AID
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CADe Colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy with the help of CADe system (ENDO-Aid)
Arm Title
Conventional Colonoscopy
Arm Type
No Intervention
Arm Description
Standard Colonoscopy with white light
Intervention Type
Device
Intervention Name(s)
ENDO-Aid by Olympus
Intervention Description
Colonoscopy assisted by ENDO-AID device
Primary Outcome Measure Information:
Title
Adenoma detection rate (ADR)
Description
ADR defined as the proportion of patients with at least 1 adenoma detected.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Polyp detection rate (PDR)
Description
PDR defined as the proportion of patients with at least 1 polyp detected.
Time Frame
1 years
Title
Polyp per colonoscopy (PPC)
Description
PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Time Frame
1 years
Title
Adenoma per colonoscopy (APC)
Description
APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Time Frame
1 years
Title
Sessile serrated lesion detection rate (SSLDR)
Description
SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies.
Time Frame
1 years
Title
Advanced adenoma detection rate (AADR)
Description
AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years or ≤85
Patients undergoing screening, follow-up, or diagnostic colonoscopy
Exclusion Criteria:
Suspected or known inflammatory bowel disease
Colonic resection
Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
Patients with incomplete colonoscopy
Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
Inability to provide informed consent.
Facility Information:
Facility Name
Fondazione Poliambulanza
City
Brescia
State/Province
Bs
ZIP/Postal Code
25124
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
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