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Completed

NCT Number: NCT05963724

Real-Time CAD for Colonic Neoplasia: A RCT

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverside University Health System

Moreno Valley, California, 92555, United States

About this study

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing colonoscopy at RUHS
  • Age > 45 years
  • No contraindications to colonoscopy

Exclusion criteria

  • Prior history of subtotal colectomy

Treatment and study plan

Real-Time Computer Aided Detection

Device

This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)

Stanford Colonoscopy

Procedure

This involves white-light colonoscopy

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 1 year

Secondary outcomes

  1. Adenomas Per Colon

    Time frame: 1 year

  2. Sessile Serrated Lesion Detection Rate

    Time frame: 1 year

  3. Sessile Serrated Lesions Per Colon

    Time frame: 1 year

  4. False Neoplasia Rate

    Time frame: 1 year

  5. Withdrawal Time

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Riverside University Health System Medical Center

Other

Registry information

Official study title

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

Acronym: CAD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jul 27, 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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