N/A
Completed N=156
Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus
Source: ClinicalTrials.gov NCT02451124 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey — 96; 31; 1; 121 number of participants
Summary
This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey |
96; 31; 1; 121; 7; 0 | — |
| PRIMARY Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE |
88 | — |
| PRIMARY Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis |
92 | — |
| PRIMARY Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays |
— | — |
| PRIMARY Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE |
— | — |
| PRIMARY Average Methylation of Zinc Finger Protein 793 Assay |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
- Patients can provide informed consent
- Patients have no known coagulopathy and no known history of esophageal varices
Exclusion Criteria
- Patients are not undergoing clinically indicated EGD
- Patients have known coagulopathies or history of esophageal varices
- Patients do not have the ability to give informed consent
Data sourced from ClinicalTrials.gov (NCT02451124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.