ACCENDO-Colo: Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero (Other)

Overall Status

Completed

CT.gov ID

NCT05862948

Collaborator

(none)

1,160

Enrollment

Locations

Arms

Actual Duration (Months)

580

Patients Per Site

32.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adenoma Colon Colonic Adenoma	Device: ENDO-Aid by Olympus	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study

Actual Study Start Date :

Oct 30, 2021

Actual Primary Completion Date :

Mar 31, 2023

Actual Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CADe Colonoscopy Colonoscopy with the help of CADe system (ENDO-Aid)	Device: ENDO-Aid by Olympus Colonoscopy assisted by ENDO-AID device
No Intervention: Conventional Colonoscopy Standard Colonoscopy with white light

Arm

Intervention/Treatment

Experimental: CADe Colonoscopy

Colonoscopy with the help of CADe system (ENDO-Aid)

Device: ENDO-Aid by Olympus

Colonoscopy assisted by ENDO-AID device

No Intervention: Conventional Colonoscopy

Standard Colonoscopy with white light

Outcome Measures

Primary Outcome Measures

Adenoma detection rate (ADR) [1 years]
ADR defined as the proportion of patients with at least 1 adenoma detected.

Secondary Outcome Measures

Polyp detection rate (PDR) [1 years]
PDR defined as the proportion of patients with at least 1 polyp detected.
Polyp per colonoscopy (PPC) [1 years]
PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Adenoma per colonoscopy (APC) [1 years]
APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Sessile serrated lesion detection rate (SSLDR) [1 years]
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) [1 years]
AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Poliambulanza	Brescia	Bs	Italy	25124
2	Policlinico Universitario Agostino Gemelli	Roma		Italy	00168

Sponsors and Collaborators

Fondazione Poliambulanza Istituto Ospedaliero

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Poliambulanza Istituto Ospedaliero

ClinicalTrials.gov Identifier:

NCT05862948

Other Study ID Numbers:

NP4834

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero

ADR

CADe

Endo-AID

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of May 17, 2023