NCT04295811 - Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC | Biotech Hunter

Enrollment

470

Participants

Timeline

Start Date

June 18, 2020

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions

Barrett EsophagusEsophageal AdenocarcinomaBarretts Esophagus With DysplasiaBarrett's Esophagus Without Dysplasia

Interventions

DEVICE

EsoGuard (lab assay)

EsoGuard assay (LDT) will be used on cells collected using the EsoCheck (510K cleared esophageal cell collection device)

DIAGNOSTIC_TEST

Esophagogastroduodenoscopy

Planned EGD to diagnose and/or treat disorders of esophagus, stomach, and small intestine. When abnormal tissues are noted, biopsies of the tissue are taken through the scope to diagnose tissue abnormalities.

Trial Locations (38)

11030

RECRUITING

Lucid Investigative Site, New Hyde Park

14620

NOT_YET_RECRUITING

Lucid Investigative Site, Rochester

19104

NOT_YET_RECRUITING

Lucid Investigative Site, Philadelphia

19107

RECRUITING

Lucid Investigative Site, Philadelphia

20007

RECRUITING

Lucid Investigative Site, Washington D.C.

21287

RECRUITING

Lucid Investigative Site, Baltimore

23249

RECRUITING

Lucid Investigative Site, Richmond

23298

RECRUITING

Lucid Investigative Site, Richmond

27599

RECRUITING

Lucid Investigative Site, Chapel Hill

29425

RECRUITING

Lucid Investigative Site, Charleston

29615

RECRUITING

Lucid Investigative Site, Greenville

32256

TERMINATED

Lucid Investigative Site, Jacksonville

35294

RECRUITING

Lucid Investigative Site, Birmingham

37212

RECRUITING

Lucid Investigative Site, Nashville

37909

RECRUITING

Lucid Investigative Site, Knoxville

39232

RECRUITING

Lucid Investigative Site, Flowood

48109

RECRUITING

Lucid Investigative Site, Ann Arbor

60611

NOT_YET_RECRUITING

Lucid Investigative Site, Chicago

63110

NOT_YET_RECRUITING

Lucid Investigative Site, St Louis

68124

RECRUITING

Lucid Investigative Site, Omaha

71105

RECRUITING

Lucid Investigative Site, Shreveport

75246

RECRUITING

Lucid Investigative Site, Dallas

77030

RECRUITING

Lucid Investigative Site, Houston

78712

NOT_YET_RECRUITING

Lucid Investigative Site, Austin

80045

RECRUITING

Lucid Investigative Site, Aurora

80113

RECRUITING

Lucid Investigative Site, Englewood

84132

RECRUITING

Lucid Investigative Site, Salt Lake City

92868

RECRUITING

Lucid Investigative Site, Orange

97239

NOT_YET_RECRUITING

Lucid Investigative Site, Portland

02215

RECRUITING

Lucid Investigative Site, Boston

03756

NOT_YET_RECRUITING

Lucid Investigative Site, Lebanon

02903

WITHDRAWN

Lucid Investigative Site, Providence

1081 HZ

RECRUITING

Lucid Investigative Site, Amsterdam

5623 EJ

RECRUITING

Lucid Investigative Site, Eindhoven

9713 GZ

RECRUITING

Lucid Investigative Site, Groningen

3435 CM

RECRUITING

Lucid Investigative Site, Nieuwegein

6525 GA

RECRUITING

Lucid Investigative Site, Nijmegen

3015 GD

RECRUITING

Lucid Investigative Site, Rotterdam