Eosinophilic Esophagitis
Conditions
Brief summary
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.
Interventions
DEVICECytosponge
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 The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.
Sponsors
University of Cambridge
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy.
Exclusion criteria
* Patients for whom clinically indicated endoscopy is not safe. Patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule. * Vulnerable populations, such as those with diminished mental acuity, will be excluded. * Patients with known Lidocaine/Acetylcysteine allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Specificity of the Cytosponge | Baseline | 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. |
| Percent Sensitivity of the Cytosponge | Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cytosponge/ Brushing 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.
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. | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to swallow Cytosponge | 6 |
Baseline characteristics
| Characteristic | Cytosponge/ Brushing |
|---|---|
| Age, Continuous | 42 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 86 Participants |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 2 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge/ Brushing | Percent Sensitivity of the Cytosponge | 75 percentage of samples |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge/ Brushing | Percent Specificity of the Cytosponge | 86 percentage of samples |