Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040, China
Location contact
Danian Ji, M.D.
CONTACT
Zhiyu Dong, M.D.
CONTACT
NCT Number: NCT07795788
A single-center prospective observational study evaluates the correlation between an AI-based bowel preparation quality score (FQ-BBPS[25%]), which quantifies fecal coverage area during colonoscopy withdrawal, and the adenoma detection rate (ADR) in screening/surveillance patients.
Trial opening soon.
Get Notified45 year–75 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200040, China
Danian Ji, M.D.
CONTACT
Zhiyu Dong, M.D.
CONTACT
The FQ-BBPS system uses image segmentation to automatically calculate the percentage of mucosa obscured by feces/fluid, providing a continuous, objective alternative to the conventional Boston Bowel Preparation Scale (BBPS). Preliminary retrospective data showed a strong correlation (Spearman ρ = -0.829) between FQ-BBPS(25%) and ADR, and adding this metric improved adenoma prediction over e-BBPS alone. This prospective study (October 2026 - September 2027) will consecutively enroll patients aged 45-75 years undergoing colonoscopy for screening or polyp surveillance, excluding those with prior colorectal surgery, cancer, alarm symptoms, anticoagulant use, or recent trial participation. With a conservative assumed correlation of -0.70, a sample size of 560 (allowing 10% dropout) is planned.
The primary outcome is ADR (proportion with ≥1 histologically confirmed adenoma), and secondary outcomes include detection rates for serrated lesions, advanced adenomas, and polyp detection by size/location; safety endpoints (perforation, immediate/delayed bleeding) will also be recorded. The FQ-BBPS(25%) score will be computed automatically from withdrawal videos, while endoscopists record BBPS and polyp characteristics. Spearman correlation will assess the association, and ROC analysis will explore the optimal cutoff against the 35% ADR reference. The study adheres to the Declaration of Helsinki, with ethics approval and written informed consent from all participants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 weeks after the procedure
Time frame: 2 weeks after the procedure
Time frame: 2 weeks after the procedure
Time frame: 2 weeks after the procedure
Contact information is provided by the study sponsor or research team.
Danian Ji, M.D.
CONTACT
Zhiyu Dong, M.D.
CONTACT
Fudan University
Other
Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate: A Single-Center, Prospective, Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07793110
Colorectal Adenoma, Pathological Conditions, Anatomical
Wuhan, Hubei, China
View Trial DetailsNCT07738484
Colorectal Adenoma, Colorectal Polyps
View Trial DetailsNCT07314554
Adenoma, Adenomatous Polyps
Lanzhou, Gansu, China
View Trial DetailsNCT07505056
Colorectal Adenoma
View Trial Details