Real-time Feedback of Red-out Within Colonoscopy Intubation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI system

    Other intervention

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

Treatment groups

576 Participants
are divided into 4 treatment groups
Group A: Group ASham comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention
Group D: Group DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Red-out percentage

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

Time frame
Stage 3 (projected to begin in 3-6 months)
2

Caecal intubation time

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

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

AI-based red-out avoiding score

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

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

Secondary outcomes

1

Complications

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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