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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05862948
Other study ID # NP4834
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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