Endoscopic Quality Improvement System Study

NCT ID: NCT04654247

Last Updated: 2020-12-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2019-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma Colon Gastric Precancerous Condition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

None feedback.

Feedback group

Endoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly.

Group Type EXPERIMENTAL

Quality audit and feedback

Intervention Type BEHAVIORAL

Endoscopists received quality report generated by Endo.Adm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality audit and feedback

Endoscopists received quality report generated by Endo.Adm.

Intervention Type BEHAVIORAL

Control

None feedback.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EA-19-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endoscopy Quality Study
NCT03351790 UNKNOWN
Impact of AI on Trainee ADR
NCT05423964 UNKNOWN NA
Application of AI in Polypectomy
NCT04485715 UNKNOWN NA