An interventional study of Cytosponge in Eosinophilic Esophagitis, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 86 is above the median of 66 across 215 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.
Device: Cytosponge
An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.
Percent Specificity of the Cytosponge
Percent specificity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing. Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens. To calculate specificity: 100% the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.
Time frame: Baseline
Percent Sensitivity of the Cytosponge
Percent sensitivity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing. Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens. To calculate sensitivity: 100% the number of true positives divided by the sum of the number of true positives plus the number of false negatives
Time frame: Baseline
| Milestone | Cytosponge/ Brushing |
|---|---|
| Started | 86 |
| Completed | 80 |
| Not completed | 6 |
| Withdrew: Unable to swallow cytosponge | 6 |
Percent specificity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing. Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens. To calculate specificity: 100% the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.
| percentage of samples | Cytosponge/ Brushing |
|---|---|
| Percent Specificity of the Cytosponge | 86 |
Percent sensitivity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing. Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens. To calculate sensitivity: 100% the number of true positives divided by the sum of the number of true positives plus the number of false negatives
| percentage of samples | Cytosponge/ Brushing |
|---|---|
| Percent Sensitivity of the Cytosponge | 75 |
Collected over Adverse events were collected from baseline to after upper endoscopy for a total of approximately 3 hours on all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytosponge/ Brushing | 0/86 (0%) | 0/86 (0%) | 2/86 (2.3%) |
| Event | Cytosponge/ Brushing |
|---|---|
| Mucosal TearGastrointestinal disorders | 2/86 |
| Age, Continuous(years) | Cytosponge/ Brushing |
|---|---|
| Median | 42 (18 to 69) |
| Sex: Female, Male(Participants) | Cytosponge/ Brushing |
|---|---|
| Female | 30 |
| Male | 56 |
| Race (NIH/OMB)(Participants) | Cytosponge/ Brushing |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 86 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cytosponge/ Brushing |
|---|---|
| United States | 86 |
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Plan to share: No
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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