Last reviewed · How we verify
NCT03859557
The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
trial in GERD in 1,032 participants. Completed in 31 December 2018.
31 December 2018
Quick facts
| Lead sponsor | CDx Diagnostics |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,032 |
| Start date | 1 October 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across United States |
Conditions studied
- GERD — all drugs for GERD →
- Barrett Esophagus — all drugs for Barrett Esophagus →
- Low Grade Esophageal Glandular Dysplasia — all drugs for Low Grade Esophageal Glandular Dysplasia →
- Esophageal Diseases — all drugs for Esophageal Diseases →
Sponsor
CDx Diagnostics — full company profile →
Who can join
18 and older, any sex, with GERD or Barrett Esophagus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Multicenter randomized controlled trial comparing forceps biopsy sampling with wide-area transepithelial sampling brush for detecting intestinal metaplasia and dysplasia during routine upper endoscopy.
DeMeester S, Smith C, Severson P, Loveitt A, et al · · 2022 · cited 3× · PMID 34902373 · DOI 10.1016/j.gie.2021.11.044
Verify or expand the search:
- PubMed search for NCT03859557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other CDx Diagnostics trials
Trials by the same sponsor.
- NCT04312633 — Clinical Utility of WATS3D: A 5-Year Prospective Study · recruiting
- NCT03015389 — Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03859557 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CDx Diagnostics
- Last refreshed: 1 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03859557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing