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NCT Number: NCT07338643

The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

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Key information

Conditions

Abdominal Pain Black Stools Constipation Diarrhea Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Melena Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Observational

Primary location

the Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location contact

Li mian Er, Doctor

CONTACT

[email protected]

13513379068

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.

Exclusion criteria

  • Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
  • Those with intestinal obstruction or malignant tumors
  • Patients with colorectal lesions that need to be treated in stages.
  • Other contraindications for colonoscopy examination.

Treatment and study plan

AI group

Procedure

Full AI assistance was used throughout the standard colonoscopy procedure.

Serial group

Procedure

After normal withdrawal of the colonoscope to the splenic flexure during standard colonoscopy, full AI assistance was initiated. The colonoscope was re-entered to the ileocecal region for observation. Any missed lesions were recorded.

Standard colonoscopy group

Procedure

The standard colonoscopy procedure was performed as usual

Primary outcomes

  1. Adenoma detection rate

    Time frame: Day 1

    The proportion of patients who have at least one adenoma detected during colonoscopy examination

  2. Average adenoma detection rate

    Time frame: Day 1

    The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.

Study contacts

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

Li mian Er, doctor

CONTACT

[email protected]

13513379068

Zhenzhen Wang, master

CONTACT

[email protected]

13803365602

Sponsors and collaborators

Lead sponsor

Limian Er

Other

Registry information

Official study title

The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer: A Multicenter Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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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