Adults 18 to 80, any sex, with Barrett's Esophagus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cytosponge Acceptability by Number of ParticipantsPrimary· 7 days after Baseline
Acceptability will be measured the Impact of Events Scale (IES). This scale was developed to assess the distress associated with a specific life event. Respondents are asked to answer questions to indicate the amount of stress from the event. Scores are calculated with the following scale, (Not at all =0, Rarely =1, Sometimes =3, Often =5). Assessment yields a cumulative score that are calculated from each response, with a total final score ranging from (0-75). High scores represent high test induced distress and lower values represent low distress.
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
46
Participants With Barrett's After Ablation
81
Participants With Barrett's and no History of Ablation
2
Participants With Barrett's After Ablation
6
Participants With Barrett's and no History of Ablation
0
Participants With Barrett's After Ablation
1
Participants With Barrett's and no History of Ablation
0
Participants With Barrett's After Ablation
0
Mean Post Procedure Pain on the Visual Analog ScalePrimary· Immediately after Cytosponge removal
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 100-mm line that represents a continuum between "no pain" and "worst pain." Higher scores are representative of worse pain.
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
19.1
± 17.7
Participants With Barrett's After Ablation
17.0
± 17.5
Willingness to Repeat Cytosponge by Number of ParticipantsPrimary· 7 days after Baseline
Participants were asked if they would be willing to repeat the Cytosponge, yes/no.
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
44
Participants With Barrett's After Ablation
86
Participants With Barrett's and no History of Ablation
3
Participants With Barrett's After Ablation
2
Mean Procedure Preference RatingPrimary· 7 days after Baseline
Participants were asked to rate both procedures (Cytosponge and esophagogastroduodenoscopy (EGD)) to indicate which procedure they preferred on a scale from 0-10. Higher scores represent greater preference.
Cytosponge Rating, On scale of 1-10
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
7.8
± 2.3
Participants With Barrett's After Ablation
7.9
± 2.0
EGD Rating, On scale of 1-10
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
The operating characteristics of the Cytosponge™ technique compared against a gold standard of upper endoscopy with biopsies for endoscopic surveillance was evaluated for sensitivity and specificity in the detection of BE in subjects with current (BE) or history of successful radiofrequency ablation for dysplastic BE. A true positive was considered when both the endoscopic biopsy and the Cytosponge detected the goblet cells characteristic of BE. A false positive was considered when the Cytosponge demonstrated these cells while the biopsies did not. A true negative occurred when neither the bio
Specificity to detect BE
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
92.00
Participants With Barrett's After Ablation
85.00
Sensitivity to detect BE
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
80.00
Participants With Barrett's After Ablation
74.00
Assay Accuracy
Group
Value
95% CI
Participants With Barrett's and no History of Ablation
NA
Participants With Barrett's After Ablation
84.00
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline until approximately 30 days after completion of biomarker panel, an overall approximate total of 45 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Participants With Barrett's and no History of Ablation
Subjects presenting to University of North Carolina at Chapel Hill (UNC) Hospitals for routine endoscopic surveillance examinations for current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed consent, and the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge assay. The patient will then undergo routine endoscopic surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge for processing according to their established protocols. Tissue biopsies will undergo standard processing and Hematoxylin and Eosin (H\&E) staining, with assessment by expert gastrointestinal pathologists at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay, compared against the gold standard of the presence of recurrent BE as detected by upper endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a visual analogue scale), and likelihood of assay positivity as a function of amount of residual disease (as measured by Prague criteria).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 20 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02106910.