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OpenTrials
Completed

NCT Number: NCT05862948

Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

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.

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Key information

Conditions

Adenoma Colon Colonic Adenoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Poliambulanza, Brescia, Bs, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ENDO-Aid by Olympus

Device

Colonoscopy assisted by ENDO-AID device

Primary outcomes

  1. Adenoma detection rate (ADR)

    Time frame: 1 years

    ADR defined as the proportion of patients with at least 1 adenoma detected.

Secondary outcomes

  1. Polyp detection rate (PDR)

    Time frame: 1 years

    PDR defined as the proportion of patients with at least 1 polyp detected.

  2. Polyp per colonoscopy (PPC)

    Time frame: 1 years

    PPC defined as total number of polyps resected divided by the total number of colonoscopies.

  3. 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.

  4. 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.

  5. 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)

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Registry information

Official study title

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

Acronym: ACCENDO-Colo

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 17, 2023
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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