Clinical trial · Interventional
CLUE: CLinical Utility Study of EsoGuard
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
NCT06030180CI-TRIAL-00091474PR-0410completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Barretts Esophagus With Dysplasia | — | UNRESOLVED | — |
| Esophagus Adenocarcinoma | Esophageal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EsoGuard | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Study
- interventionNames
- Device: EsoGuard
Primary outcomes (1)
- measure
- Clinical Utility
- timeFrame
- Through study completion, an average of 1 year
- description
- Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.
Secondary outcomes (1)
- measure
- Patient Compliance
- timeFrame
- Through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG 2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update. Exclusion Criteria: 1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU) 2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening 3. Inability to provide written informed consent or participate in the required follow up
References
Publications (0)
Data not yet available
No reference posted for this study.