Health TrialsbyHealthPanel

Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

ConditionAdenoma Detection Rate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorE-DA Hospital

About this trial

Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes

Bleeding tendency

For scheduled endoscopic treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial intelligence

    Device

    ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma

  • Endocuff vision

    Device

    Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma

  • High-definition endoscope

    Device

    High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Artificial Intelligence-assisted Colonoscopy with Endocuff VisionActive comparator 3 interventions
Group B: Artificial Intelligence-assisted ColonoscopyActive comparator 2 interventions
Group C: Standard colonoscopySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adenoma detection rate

The proportion of patients with at least one adenomas

Time frame
One month after colonoscopy

Secondary outcomes

1

Polyp detection rate

The proportion of patients with at least one polyp

Time frame
One month after colonoscopy
2

Sessile serrated adenoma detection rate

The proportion of patients with at least one sessile serrated adenoma

Time frame
One month after colonoscopy
3

Sessile serrated polyps detection rate

The proportion of patients with at least one sessile serrated polyp

Time frame
One month after colonoscopy
4

Advanced adenoma detection rate

The proportion of patients with at least one advanced adenoma

Time frame
One month after colonoscopy

Other outcomes

Sponsors and contacts

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

E-DA Hospital

Lead sponsor

Chung Shan Medical University

Collaborator

Source ClinicalTrials.gov
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