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NCT Number: NCT07273890

Real-time Feedback of Red-out Within Colonoscopy Intubation

This study will employ a prospective, multicenter, controlled design. It will be conducted across multiple centers, with participated centers randomly assigned to one of four groups: Group A, Group B, Group C, and Group D.

The research will primarily focus on the AI-based analysis of colonoscopic images to calculate the following metrics: caecal intubation time, red-out percentage, and the AI-based red-out avoiding score. Based on the study's implementation protocol, a decision will be made regarding whether to provide real-time feedback. Additionally, the presence of any complications will be assessed both during and after the colonoscopy procedure.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Study Participants (Patients):

Aged 18 to 70 years, any gender. Individuals scheduled to undergo diagnostic or screening colonoscopy at the investigational site.

  • Colonoscopists:

Expert-level colonoscopists (having performed a total of >1000 colonoscopy procedures).

Right-handed.

Exclusion criteria

  • Study Participants (Patients):

Individuals undergoing the following procedures:

cases with a history of colorectal surgery; cases with a history of chemotherapy, raditherapy; cases with a history of abdominal, and/or pelvic surgery; cases with a history of difficult colonoscopies; cases with colorectal tumours and obstructive lesions; cases with colorectal diverticula; cases with ulcerative colitis or Crohn's disease; cases with ischemic bowel disease; cases with colorectal polyposis; cases with melanosis coli; cases undergoing sigmoidoscopy; cases with poor intestional cleanliness (segment Boston bowel preparation scale (BBPS) of < 2 points, total BBPS of < 6 points); cases undergoing therapy procedures such as biopsy or CSP during the intubation phase; cases with transparent cap assisted colonoscopy; cases with water-assisted colonoscopy; cases with air insufflation level of M or L; cases failed caecal intubation within 15 min; cases with colonoscope stiffness level > 0; obese cases or underweight cases; and cases refusing participation.

Individuals who decline to provide informed consent.

  • Colonoscopists:

Those who have performed fewer than 300 complete colonoscopies in any calendar year within the past three years.

Those who decline to participate in the study.

Treatment and study plan

AI system

Other

AI-system Performance Feedback in group B, group C, and group D.

Primary outcomes

  1. Red-out percentage

    Time frame: Stage 3 (projected to begin in 3-6 months)

    The impact of real-time feedback on red-out percentage.

  2. Caecal intubation time

    Time frame: Stage 3 (projected to begin in 3-6 months)

    The impact of real-time feedback on caecal intubation time.

  3. AI-based red-out avoiding score

    Time frame: Stage 3 (projected to begin in 3-6 months)

    The impact of real-time feedback on AI-based red-out avoiding score.

Secondary outcomes

  1. Complications

    Time frame: Stage 3 (projected to begin in 3-6 months)

    During and after the colonoscopy, assess for any signs of complications

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

Prospective, Multicenter, Controlled Study on the Impact of Real-time Feedback on Red-out

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Dec 10, 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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