Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
ACCENDO-Colo
1 other identifier
interventional
1,160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFirst Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedMay 17, 2023
May 1, 2023
1.4 years
May 4, 2023
May 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate (ADR)
ADR defined as the proportion of patients with at least 1 adenoma detected.
1 years
Secondary Outcomes (5)
Polyp detection rate (PDR)
1 years
Polyp per colonoscopy (PPC)
1 years
Adenoma per colonoscopy (APC)
1 years
Sessile serrated lesion detection rate (SSLDR)
1 years
Advanced adenoma detection rate (AADR)
1 years
Study Arms (2)
CADe Colonoscopy
EXPERIMENTALColonoscopy with the help of CADe system (ENDO-Aid)
Conventional Colonoscopy
NO INTERVENTIONStandard Colonoscopy with white light
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years or ≤85
- Patients undergoing screening, follow-up, or diagnostic colonoscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fondazione Poliambulanza
Brescia, Bs, 25124, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Related Publications (1)
Spada C, Salvi D, Ferrari C, Hassan C, Barbaro F, Belluardo N, Grazioli LM, Milluzzo SM, Olivari N, Papparella LG, Pecere S, Pesatori EV, Petruzziello L, Piccirelli S, Quadarella A, Cesaro P, Costamagna G. A comprehensive RCT in screening, surveillance, and diagnostic AI-assisted colonoscopies (ACCENDO-Colo study). Dig Liver Dis. 2025 Mar;57(3):762-769. doi: 10.1016/j.dld.2024.12.023. Epub 2025 Jan 14.
PMID: 39814659DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2023
First Posted
May 17, 2023
Study Start
October 30, 2021
Primary Completion
March 31, 2023
Study Completion
April 30, 2023
Last Updated
May 17, 2023
Record last verified: 2023-05