The Analysis of WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) Increased Yield of Barrett's Esophagus and Esophageal Dysplasia
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2018 |
| Start Date: | March 2002 |
| End Date: | December 2020 |
| Contact: | Rivka Rotberg |
| Email: | rrotberg@cdxdiagnostics.com |
| Phone: | 845-368-7444 |
Patients will be recruited from participating institutions prior to planned routine care EGD
with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who
are potentially eligible for the study will be approached regarding the study. If interested,
participants will be consented and proceed with routine care EGD. The study coordinator or
other research personnel will document information from the routine care endoscopy as part of
this research study. Follow-up information collected will include WATS3D cytology and forceps
biopsy pathology results from any routine care endoscopy performed during the course of
participation in the study, any surgeries received and related to their condition, and any
other care received as part of their condition. WATS3D samples will be sent to CDx
Diagnostics for analysis.
with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who
are potentially eligible for the study will be approached regarding the study. If interested,
participants will be consented and proceed with routine care EGD. The study coordinator or
other research personnel will document information from the routine care endoscopy as part of
this research study. Follow-up information collected will include WATS3D cytology and forceps
biopsy pathology results from any routine care endoscopy performed during the course of
participation in the study, any surgeries received and related to their condition, and any
other care received as part of their condition. WATS3D samples will be sent to CDx
Diagnostics for analysis.
Inclusion Criteria:
1. Both males and females at least 18 years of age undergoing EGD to evaluate signs or
symptoms suggestive of upper gastrointestinal disease.
2. Patients with known GERD undergoing a screening EGD with accompanying WATS3D biopsies
and forceps biopsies.
3. Patients with known BE undergoing a surveillance EGD with accompanying WATS3D biopsies
and forceps biopsies.
4. Patients with a known prior history (recent or remote) of dysplasia of either
indefinite, low grade or high-grade, or intramucosal adenocarcinoma undergoing a
surveillance EGD with accompanying WATS3D biopsies and forceps biopsies.
5. Patients who have undergone radiofrequency ablation orcryoablation who are undergoing
surveillance EGD with accompanying WATS3D biopsies and forceps biopsies will be
included in the study. The results of this group of patients will be analyzed
separately from patients undergoing screening and surveillance who have not been
ablated.
6. Institutional Review Board (IRB)-approved consent must be signed by patients to
participate in this study.
Exclusion Criteria:
1. Patients who on their initial evaluation 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.
2. Patients who do not undergo both Forceps Biopsy and WATS3D biopsy of the esophagus.
Subsequent endoscopic evaluation may include forceps biopsies alone, WATS3D biopsies
alone, both forceps and WATS3D biopsies, or no biopsies.
3. Patients with visible lesions that are either submucosal or covered with intact
epithelium.
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