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NCT Number: NCT07308743

Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate

This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • Study Centers 1) Nanfang Hospital, Southern Medical Univerisity, Guangzhou, China 2) The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai, China 3) Longgang District People's Hospital of Shenzhen, Shenzhen, China 4) Yangjiang People's Hospital, Yangjiang, China 5) Jiangmen Central Hospital, Jiangmen, China 6) Huizhou Third People's Hospital, Huizhou, China 7) Dongguan Shuixiang Central Hospital, Dongguang, China 8) Pingshan District People's Hospital of Shenzhen, Shenzhen, China
  • Study population 1) Inclusion criteria:
  • Patients age 40-75 years old, regardless of gender
  • Patients presenting for physical examination, colorectal cancer screening or diagnosis
  • Patients voluntarily signs an informed consent form 2) Exclusion criteria:

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  • Unable to cooperate ot tolerate colonoscopy
  • History of inflammatory bowel disease
  • History of colorectal cancer
  • Previous colorectal surgery
  • History of recurrent constipation
  • Taking anticoagulant and antiplatelet drugs berfore procedure
  • High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
  • Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
  • Post-randomization exclusion criteria:

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  • Cecum could not be intubated for various reasons
  • Boston Bowel Preparation Scale (BBPS) score of the proximal colon is <2
  • Study design This is a prospective , multicenter randomized controlled trial comparing the miss rates of proximal colonic lesions (including adenomas, SSLs, and polyps) by computer-aided detection-assisted colonoscopy or conventional colonoscopy. The study will be conducted in the Endoscopy Centre of the participating hospitals.
  • Randomization 1) Eligible patients at each center will be randomized (1:1) to computer-aided detection-assisted colonoscopy first or conventional white light colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The proximal colon is defined as the colonic segment proximal to the hepatic flexure.
  • Randomization will be performed using computer-generated random sequences in blocks of 6, with stratification by academic level of participation center, experience of endoscopists, and indications of colonoscopy. Patients will be blinded to their group assignment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients age 40-75 years old, regardless of gender
  • Patients presenting for physical examination, colorectal cancer screening or diagnosis
  • Patients voluntarily signs an informed consent form

Exclusion criteria

  • Unable to cooperate ot tolerate colonoscopy
  • History of inflammatory bowel disease
  • History of colorectal cancer
  • Previous colorectal surgery
  • History of recurrent constipation
  • Taking anticoagulant and antiplatelet drugs berfore procedure
  • High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
  • Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.

Treatment and study plan

Computer-aided detection-assisted colonoscopy

Device

Computer-aided detection-assisted colonoscopy for detection of colonic polyp

Conventional white-light colonoscopy

Procedure

Conventional white-light colonoscopy

Primary outcomes

  1. Proximal adenoma missed rate

    Time frame: One day

    The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.

Secondary outcomes

  1. Proximal polyp missed rate

    Time frame: One day

    The number of polyps identified during the second right colon inspection divided by the overall number of polyps identified during the first and second right colon inspection.

  2. Proximal SSLs missed rate

    Time frame: One days

    The number of SSLs identified during the second right colon inspection divided by the overall number of SSLs identified during the first and second right colon inspection.

  3. Proximal advanced adenoma missed rate

    Time frame: One day

    The number of advanced adenomas identified during the second right colon inspection divided by the overall number of advanced adenomas identified during the first and second right colon inspection.

Study contacts

Contact information is provided by the study sponsor or research team.

Bitao Lin, MD

CONTACT

[email protected]

+86 137-2532-1385

Zelong Han, MD, PhD

CONTACT

[email protected]

+86 189-2506-1890

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Dongguan Shuixiang Central Hospital
  • Jiangmen Central Hospital
  • Longgang District People's Hospital of Shenzhen
  • Pingshan District People's Hospital of shenzhen
  • The Fifth Affiliated Hospital of Zunyi Medical College
  • The Third People's Hospital of Huizhou
  • Yangjiang People's Hospital

Registry information

Official study title

Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

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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