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NCT07307547Not yet recruiting

Effectiveness of Artificial Intelligence-Assisted Colonoscopy for Adenoma Detection in Routine Clinical Practice : a Prospective Multicenter Randomized Trial

A Multi-center, Randomized, Controlled Clinical Study on the Effectiveness of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions in Routine Clinical Practice Across Tertiary Academic Medical Centers

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed lesions. This trial aims to determine if AI can enhance screening quality and diagnostic accuracy.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
3300 (estimated)
First submitted
14 Dec 2025
Start date
Sept 2026
Primary completion date
Dec 2028
Lead sponsor
Zhejiang University
NCT number
NCT07307547

What you commit to

  • Study type: Interventional
  • Planned participants: 3300
  • From Sept 2026 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of colon cancer or previous colonic surgery.
  • Participation in another drug or medical device clinical trial within 1 month before enrollment.

Other illness

  • Bowel obstruction; confirmed or highly suspected colorectal cancer; inflammatory bowel disease; or active colorectal bleeding.
  • Colorectal polyposis, including a history of familial adenomatous polyposis.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for this trial.
    • Withdrawal Criteria:
  • Failure to reach the cecum.

Other

  • Known contraindication to colonoscopy or to biopsy.
  • Pregnancy or breastfeeding.
  • Withdrawal of consent by the participant.
  • Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score below 6 or any segment score below 2.
  • Newly diagnosed active colitis during the procedure.

Who the study is looking for

  • Age 40 to 74 years, inclusive; men and women.
  • Scheduled for elective screening, diagnostic, or surveillance colonoscopy.
  • In generally good condition, mentally competent, and willing to provide written informed consent.

Age in the registry: 40 years to 74 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.