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

May 15, 2023 updated by: Fondazione Poliambulanza Istituto Ospedaliero

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
    • Bs
      • Brescia, Bs, Italy, 25124
        • Fondazione Poliambulanza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate (ADR)
Time Frame: 1 years
ADR defined as the proportion of patients with at least 1 adenoma detected.
1 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP4834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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