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Endoscopic Quality Improvement System Study

A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654247
Enrollment
17
Registered
2020-12-04
Start date
2019-04-20
Completion date
2019-11-25
Last updated
2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon, Gastric Precancerous Condition

Brief summary

We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.

Interventions

BEHAVIORALQuality audit and feedback

Endoscopists received quality report generated by Endo.Adm.

BEHAVIORALControl

None feedback.

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Endoscopist: 1. Endoscopist with more than one year experience in gastrointestinal mirror operation; 2. Willing to further improve endoscopic quality through Endo.Adm feedback; 3. Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.

Exclusion criteria

Endoscopist: 1. Have participated in other clinical trials; 2. Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations; 3. Endoscopist who were either not present for both parts (phase1 and phase2) of the study. Patients: Colonoscopy: 1. Polyposis syndromes 2. Lumen obstruction 3. History of colorectal surgery 4. History of colorectal surgery Gastroscopy: 1. Obstruction 2. History of gastric surgery

Design outcomes

Primary

MeasureTime frameDescription
Adenoma detection rate3 MonthsADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Gastric precancerous detection rate3 MonthsGPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.

Secondary

MeasureTime frameDescription
Adcanced ADR3 monthsAdcanced ADR was calculated by dividing the total number of patients being detected ≥10mm in size, or adenomas with histopathology of tubulovillous, villous, adenocarcinoma, or high-grade dysplasia by the number of colonoscopies.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026