NCT03008980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

December 23, 2016

Last Update Submit

October 27, 2021

Conditions

Barrett EsophagusEsophageal DysplasiaEsophagus Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.

    up to 18 years

Study Arms (7)

Community GI Group

Diagnostic Test

Other: Diagnostic Test

Academic GI Group

Diagnostic Test

Other: Diagnostic Test

Academic Esophageal Dysplasia and Cancer

Diagnostic Test

Other: Diagnostic Test

Community Barrett's Esophagus Screening

Diagnostic Test

Other: Diagnostic Test

Community Esophageal Dysplasia

Diagnostic Test

Other: Diagnostic Test

Post-Ablation BE and Esophagus Dysplasia

Diagnostic Test

Other: Diagnostic Test

GERD, BE, and Esophageal Dysplasia

Diagnostic Test

Other: Diagnostic Test

Interventions

Diagnostic TestOTHER
Academic Esophageal Dysplasia and CancerAcademic GI GroupCommunity Barrett's Esophagus ScreeningCommunity Esophageal DysplasiaCommunity GI GroupGERD, BE, and Esophageal DysplasiaPost-Ablation BE and Esophagus Dysplasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with known Barrett's Esophagus.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike Smith

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • 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.

    PMID: 28757316DERIVED

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 4, 2017

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

December 1, 2018

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(1)