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Not yet recruiting NCT07273890

Real-time Feedback of Red-out Within Colonoscopy Intubation

No phase Interventional Artificial Intelligence Colonoscopy Real-time Feedback

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: AI system.
Who it may be relevant to
Registry conditions: Artificial Intelligence, Colonoscopy, Real-time Feedback. Basic parameters: 18 years — 70 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Red-out percentage [Time frame: Stage 3 (projected to begin in 3-6 months)]
  • Caecal intubation time [Time frame: Stage 3 (projected to begin in 3-6 months)]
  • AI-based red-out avoiding score [Time frame: Stage 3 (projected to begin in 3-6 months)]
Secondary outcome measures (1)
  • Complications [Time frame: Stage 3 (projected to begin in 3-6 months)]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07273890 · AHMU-Feedback of Red-out

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗