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

NCT ID: NCT04591145

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adenoma Bowel Preparation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational group

Patients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record.

Observational group

Intervention Type OTHER

Patient receive the standard bowel preparation strategy and routine colonoscopy

Interventions

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Observational group

Patient receive the standard bowel preparation strategy and routine colonoscopy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan Central Hospital

OTHER

Sponsor Role collaborator

Wuhan Third Hospital

OTHER

Sponsor Role collaborator

The General Hospital of Central Theater Command

OTHER

Sponsor Role collaborator

The Third People's Hospital of Hubei Province

OTHER

Sponsor Role collaborator

Wuhan Puren Hospital

OTHER

Sponsor Role collaborator

Wuhan Puai Hospital

UNKNOWN

Sponsor Role collaborator

Tian You Hospital Affiliated to Wuhan University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Wuhan Red Cross Hospital

UNKNOWN

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Honggang Yu, MD

Role: CONTACT

+8613871281899

Facility Contacts

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Honggang Yu, MD

Role: primary

+8613871281899

Other Identifiers

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EA-20-002

Identifier Type: -

Identifier Source: org_study_id

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