Trial Outcomes & Findings for Detection of Barrett s Esophagus in Patients Without GERD Symptoms (NCT NCT04880044)
NCT ID: NCT04880044
Last Updated: 2026-03-10
Results Overview
PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Up to 2 months
Results posted on
2026-03-10
Participant Flow
Participant milestones
| Measure |
EC/EG & EGD
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
EsoCheck/EsoGuard (EC/EG): EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
EC/EG & EGD
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
EsoCheck/EsoGuard (EC/EG): EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
|
|---|---|
|
Overall Study
Physician Decision
|
8
|
Baseline Characteristics
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Baseline characteristics by cohort
| Measure |
EC/EG & EGD
n=132 Participants
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
EsoCheck/EsoGuard (EC/EG): EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
|
|---|---|
|
Age, Customized
40-49
|
0 Participants
n=68 Participants
|
|
Age, Customized
50-59
|
62 Participants
n=68 Participants
|
|
Age, Customized
60-69
|
52 Participants
n=68 Participants
|
|
Age, Customized
70-79
|
16 Participants
n=68 Participants
|
|
Age, Customized
80-89
|
2 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Up to 2 monthsPopulation: Only participants who underwent EGD and meet criteria for PPV calculation were included. 83 participants were not included, as they did not meet these criteria.
PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Outcome measures
| Measure |
EC/EG & EGD
n=49 Participants
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
EsoCheck/EsoGuard (EC/EG): EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
|
|---|---|
|
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
|
33 Percentage of screened participants
Interval 17.0 to 54.0
|
PRIMARY outcome
Timeframe: Up to 2 monthsPopulation: Only participants who underwent EGD and meet criteria for NPV calculation were included. 92 participants were not included, as they did not meet these criteria.
Negative Predictive Value (NPV): Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.
Outcome measures
| Measure |
EC/EG & EGD
n=40 Participants
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
EsoCheck/EsoGuard (EC/EG): EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
Esophago-gastro-duodenoscopy (EGD): SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
|
|---|---|
|
Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD
|
100 Percentage of screened participants
Interval 85.0 to 100.0
|
Adverse Events
EC/EG & EGD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amitabh Chak, M.D., Principal Investigator
University Hospitals, Case Comprehensive Cancer Center
Phone: (216) 844-3217
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place