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Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System

W

Wuhan University

Status

Unknown

Conditions

Bowel Preparation
Adenoma

Treatments

Other: Observational group

Study type

Observational

Funder types

Other

Identifiers

NCT04591145
EA-20-002

Details and patient eligibility

About

A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.

Full description

Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.

Enrollment

1,400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female aged 18 years or above;
  • Ability to read, understand and sign informed consent forms;
  • The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion criteria

  • Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
  • Patients with galactosemia;
  • Pregnant or lactating women;
  • Patients used lactulose, a stimulant, or laxative within 7 days;
  • Patients refused to sign informed consent forms.

Trial design

1,400 participants in 1 patient group

Observational group
Description:
Patients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record.
Treatment:
Other: Observational group

Trial contacts and locations

1

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Central trial contact

Honggang Yu, MD

Data sourced from clinicaltrials.gov

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