AI-assisted Gastroscopic Varicose Vein Diagnosis

NCT05293457 | Unknown DMC

• 1 other identifier: WDRY2022-K014
• Study Type: observational
• Target: 793
• Locations: 1 country
• Sites: 1

Brief Summary

Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study

Conditions

Artificial Intelligence

Keywords

artificial intelligence; Varicose veins; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• The accuracy of artificial intelligence

  Accuracy of AI in the description and treatment recommendations of esophagogastric varices diagnosis and endoscopic findings (form, color, red sign, hemorrhagic sign, and mucosal findings).

  2022/12/25

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis who visited each center of the study from February 2022 to December 2022.

You may qualify if:

• Male or female aged 18 years or above;
• Gastroscopy and related examinations are required to further clarify the characteristics of digestive tract diseases;
• Patients with liver cirrhosis who have signs or symptoms of portal hypertension and have clinical indications for endoscopic screening for varicose veins.
• Able to read, understand and sign the informed consent;
• The researcher believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

You may not qualify if:

• \) Pregnant or breastfeeding women; 2) Patients with a history of esophagogastric surgery; 3) Patients who have received interventional or endoscopic treatment in the past; 4) The patient has high-risk diseases or other special conditions that are not suitable for participating in clinical trials; 5) The patient is clearly diagnosed with esophageal or gastric diverticulum, polyps, cancer and other diseases that may affect the observation of varicose veins; 6) The patient's endoscopic video cannot reach a consensus diagnosis and treatment opinion after being watched by three experts.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Conditions

Varicose Veins; Fibrosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: March 24, 2022
• Study Start: April 25, 2022
• Primary Completion: October 25, 2022
• Study Completion: December 25, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CN (1)