Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

Adenoma Colon Clinical Trial

— ACCENDO-Colo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862948
• Other study ID #: NP4834
• Status: Completed
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Adenoma

Intervention

Device:
• ENDO-Aid by Olympus
Colonoscopy assisted by ENDO-AID device

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza	Brescia	Bs
Italy	Policlinico Universitario Agostino Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate (ADR)	ADR defined as the proportion of patients with at least 1 adenoma detected.	1 years
Secondary	Polyp detection rate (PDR)	PDR defined as the proportion of patients with at least 1 polyp detected.	1 years
Secondary	Polyp per colonoscopy (PPC)	PPC defined as total number of polyps resected divided by the total number of colonoscopies.	1 years
Secondary	Adenoma per colonoscopy (APC)	APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.	1 years
Secondary	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.	1 years
Secondary	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)	1 years