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Completed

NCT Number: NCT04884581

Characterization of Colorectal Neoplasia

This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuovo Regina Margherita

Roma, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 40 years or older undergoing screening colonoscopy for CRC
  • Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation

Exclusion criteria

  • subjects at high risk for colorectal cancer
  • subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
  • patients with previous resection of the sigmoid rectum
  • patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
  • patients who perform an emergency colonoscopy

Treatment and study plan

GI Genius CADx device

Device

GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.

Primary outcomes

  1. Negative Predictive Value (NPV)

    Time frame: 4 months

    Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps

Other outcomes

  1. Post-polypectomy surveillance interval

    Time frame: 4 months

    Agreement in assignment of post-polypectomy surveillance intervals of the enrolled patients according to established guidelines between the combined use of GI Genius CADx as optical diagnosis for diminutive (≤5 mm) polyps and conventional histology as diagnostic tool for polyps > 5 mm, and histology as diagnostic tool for all the resected polyps (regardless of size or location)

  2. Performance metrics of GI Genius CADx

    Time frame: 4 months

    Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx optical diagnosis

  3. Performance metrics of the endoscopist with the aid of GI Genius CADx

    Time frame: 4 months

    Sensitivity, Specificity, Accuracy, PPV and NPV of the optical diagnosis of endoscopists assessing lesions in white-light with the help of GI Genius CADx.

Sponsors and collaborators

Lead sponsor

Nuovo Regina Margherita Hospital

Other

Registry information

Official study title

The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy

Acronym: CHANGE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Aug 6, 2021

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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