Clinical Utility of WATS3D: A 5-Year Prospective Study

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    90000
  • sponsor
    CDx Diagnostics
Updated on 3 August 2021
regurgitation
heartburn
dysplasia
radiofrequency ablation
intestinal metaplasia
metaplasia
acidity

Summary

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

Description

This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment.

In addition , by recording the results of all your biopsies over 5 years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer.

You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of you standard clinical care, and you are at least 18 years old.

Details
Condition Esophageal Diseases, Gastroesophageal Reflux, GASTROINTESTINAL DISORDER, Precancerous Conditions, BARRETT'S ESOPHAGUS, Gastroesophageal Reflux Disease (GERD), Gastrointestinal Diseases and Disorders, Esophageal Dysplasia, Esophageal Disorders, Precancerous condition, gastroesophageal reflux disease, esophageal reflux, gerd, gastric reflux, gastro-oesophageal reflux
Clinical Study IdentifierNCT04312633
SponsorCDx Diagnostics
Last Modified on3 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to read, comprehend and complete the IRB-approved consent form
Aged 18 or older
Meet one of the following
Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)
Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included

Exclusion Criteria

Pregnancy at time of endoscopy
Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
Medical condition that will likely prohibit completion of a 5 year study
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How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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