NCT04591145

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 12, 2020

Last Update Submit

October 12, 2020

Conditions

AdenomaBowel Preparation

Outcome Measures

Primary Outcomes (2)

  • Cleanliness assessment of different intestinal segment in the artificial intelligence system

    The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 0-1 Score

    3 Months

  • Adenoma detection rate

    The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.

    3 Months

Secondary Outcomes (10)

  • Advanced adenoma detection rate

    3 Months

  • Polyps detection rate

    3 Months

  • The mean number of adenomas per procedure

    3 Months

  • Detection rate of large, small and diminutive polyps

    3 Months

  • The mean number of large, small and diminutive polyps per procedure

    3 Months

  • +5 more secondary outcomes

Study Arms (1)

Observational group

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

Other: Observational group

Interventions

Observational groupOTHER

Patient receive the standard bowel preparation strategy and routine colonoscopy

Observational group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Continuous colonoscopy from October to December 2020 will be collected in our participating general hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Honggang Yu, MD

CONTACT

+8613871281899yuhonggang1968@163.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 9, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

CN(1)