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Not yet recruiting NCT07308743

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

No phase Interventional Colon Adenomas Colon Polyps Sessile Serrated Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer-aided detection-assisted colonoscopy, Conventional white-light colonoscopy.
Who it may be relevant to
Registry conditions: Colon Adenomas, Colon Polyps, Sessile Serrated Lesion. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

1. 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 2. Study population 1) Inclusion criteria:

1. Patients age 40-75 years old, regardless of gender 2. Patients presenting for physical examination, colorectal cancer screening or diagnosis 3. Patients voluntarily signs an informed consent form 2) Exclusion criteria:

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1. Unable to cooperate ot tolerate colonoscopy 2. History of inflammatory bowel disease 3. History of colorectal cancer 4. Previous colorectal surgery 5. History of recurrent constipation 6. Taking anticoagulant and antiplatelet drugs berfore procedure 7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections 8. Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.

3\) Post-randomization exclusion criteria:

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1. Cecum could not be intubated for various reasons 2. Boston Bowel Preparation Scale (BBPS) score of the proximal colon is \<2 3. 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. 4. 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.

2\) 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.

Interventions

  • Device Computer-aided detection-assisted colonoscopy
    Computer-aided detection-assisted colonoscopy for detection of colonic polyp
  • Procedure Conventional white-light colonoscopy
    Conventional white-light colonoscopy

Primary outcome measures

  • Proximal adenoma missed rate [Time frame: One day]
Secondary outcome measures (3)
  • Proximal polyp missed rate [Time frame: One day]
  • Proximal SSLs missed rate [Time frame: One days]
  • Proximal advanced adenoma missed rate [Time frame: One day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT07308743 · NFEC-2025-679

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗