The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/2/2019 |
| Start Date: | April 2016 |
| End Date: | April 2026 |
| Contact: | Stephanie Pille |
| Email: | pstephanie@cdxdiagnostics.com |
| Phone: | 8453687452 |
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.
By recording the results of all of your biopsies over many 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. The data from your
biopsies will be used to determine the best way to diagnose esophageal disease.
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 your standard clinical
care, and you are between the ages of 18 and 80.
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.
By recording the results of all of your biopsies over many 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. The data from your
biopsies will be used to determine the best way to diagnose esophageal disease.
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 your standard clinical
care, and you are between the ages of 18 and 80.
Inclusion Criteria:
- English speaking
- Able to read, comprehend, and complete the consent form
- Aged 18 to 80, and,
- 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 therapy(including, but not limited
to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency
ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD
following the establishment of complete eradication of intestinal metaplasia (CEIM)
with accompanying WATS3D sampling and forceps biopsies.
Exclusion Criteria:
- Patients meeting any of the following criteria will be excluded from this study:
- Patients who on their enrollment endoscopy have a visible highly suspicious lesion,
such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted
biopsy will be excluded from the study.Patients requiring a targeted biopsy on
follow-up endoscopies will be allowed to remain in the study.
- Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on
their initial evaluationfor routine care will be excluded from this study. Subsequent
endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or
both forceps and WATS3D biopsies.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-7655
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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