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WATS3D for the Detection of Esophageal Dysplasia

NCT ID: NCT03008980

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Barrett Esophagus Esophageal Dysplasia Esophagus Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Community GI Group

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Academic GI Group

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Academic Esophageal Dysplasia and Cancer

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Community Barrett's Esophagus Screening

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Community Esophageal Dysplasia

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Post-Ablation BE and Esophagus Dysplasia

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

GERD, BE, and Esophageal Dysplasia

Diagnostic Test

Diagnostic Test

Intervention Type OTHER

Interventions

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Diagnostic Test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients age: ≥ 18 years
* Patients should have a history of Barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
* Willingness to undergo both WATS and forceps biopsies while undergoing conventional EGD with sedation
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* Only patients who undergo both forceps biopsies and WATS of the esophagus will be included in this study

Exclusion Criteria

* Coagulopathy with an international normalized ratio above 2.0;
* Thrombocytopenia with platelet counts below 50,000
* History of prior esophageal ablation therapies, esophageal or gastric surgery
* Unresolved drug or alcohol dependency
* Pregnancy or planned pregnancy during the study period
* Patients found to have a BE length less than 1 cm or greater than 10 cm
* Patients with any visible lesions greater than 10 mm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rockford Gastroenterology Associates

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

CDx Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mike Smith

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Vennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.

Reference Type DERIVED
PMID: 28757316 (View on PubMed)

Other Identifiers

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CDx 103

Identifier Type: -

Identifier Source: org_study_id