Clinical Utility of WATS3D: A 5-Year Prospective Study

Last updated: August 19, 2024
Sponsor: CDx Diagnostics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04312633
CDx 906
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 undergoWATS3D sampling and forceps biopsies for suspicion of BE, or

  • Patients with known BE with or without dysplasia undergoing a surveillance EGD withWATS3D biopsies and forceps biopsies, or

  • Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation orcryoablation) who are undergoing surveillance EGD following the establishment ofcomplete eradication of intestinal metaplasia (CEIM)

  • Only patients who undergo both forceps biopsies and WATS3D of the esophagus will beincluded.

Exclusion

Exclusion Criteria:

  • Pregnancy at time of endoscopy

  • Unresolved drug or alcohol dependency that will limit ability to comprehend orfollow instructions related to informed consent, post-treatment instructions orfollow-up guidelines

  • Medical condition that will likely prohibit completion of a 5 year study

Study Design

Total Participants: 90000
Study Start date:
April 01, 2020
Estimated Completion Date:
November 01, 2027

Study 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.

Connect with a study center

  • NYU Langone Ambulatory Care

    Bethpage, New York 11714
    United States

    Active - Recruiting

  • ProHEALTH Care Associates, LLP

    Lake Success, New York 11042
    United States

    Site Not Available

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