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NCT Number: NCT06504134

Gastroesophageal Reflux Disease Diagnostic Trial

Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years and ≤85 years, male or female;
  • A visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching;
  • Patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up.

Exclusion criteria

  • History of esophageal surgery;
  • Presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis;
  • Presence of coagulation disorders or taking anticoagulant or antiplatelet drugs;
  • Those with a life expectancy of less than 5 years;
  • Persons with mental anomalies who are incapable of behavioral autonomy;
  • Other conditions that, in the judgment of the physician, preclude participation in the trial.

Treatment and study plan

the Novel Esophageal Cell Collection Device

Diagnostic Test

Using the novel cell collection device and the deep learning method to collect and classify esophogeal cell to identify if the participants are GERD patients

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 60 minutes

    sensitivity and specificity

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Xin, MD

CONTACT

[email protected]

13817318134

Luowei Wang, MD

CONTACT

[email protected]

13901833088

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Ruijin Hospital
  • Shanghai Tongji Hospital, Tongji University School of Medicine
  • The Second Affiliated Hospital of Baotou Medical College
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital

Registry information

Acronym: GERDT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

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.

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