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Impact of Automatic Polyp Detection System on Adenoma Detection Rate

N

Naval Military Medical University

Status

Unknown

Conditions

Colonic Polyps
Colorectal Adenomas

Treatments

Device: Automatic polyp detection system

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

In recent years, with the continuous development of artificial intelligence, automatic polyp detection systems have shown its potential in increasing the colorectal lesions. Yet, whether this system can increase polyp and adenoma detection rates in the real clinical setting is still need to be proved. The primary objective of this study is to examine whether a combination of colonoscopy and a deep learning-based automatic polyp detection system is a feasible way to increase adenoma detection rate compared to standard colonoscopy.

Enrollment

1,118 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged between 40-85 years old who have indications for screening, surveillance and diagnostic.
  • Patients who have signed inform consent form.

Exclusion criteria

  • Patients who have undergone colonic resection
  • Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
  • Patients with severe chronic cardiopulmonary and renal disease.
  • Patients who are unwilling or unable to consent.
  • Patients who are not suitable for colonoscopy
  • Patients who received urgent or therapeutic colonoscopy
  • Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
  • Patients who are taking aspirin, clopidogrel or other anticoagulants
  • Patients with withdrawal time < 6 min

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,118 participants in 2 patient groups

AI-assisted withdrawal group
Experimental group
Description:
A deep learning-based automatic polyp detection system was used to assist the endoscopist.
Treatment:
Device: Automatic polyp detection system
Routine withdrawal group
No Intervention group
Description:
Routine withdrawal without any assist.

Trial contacts and locations

1

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Central trial contact

Yu Bai, M.D; Zhaoshen Li, M.D

Data sourced from clinicaltrials.gov

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