Trial Outcomes & Findings for Cytosponge Adequacy Study Evaluation II (NCT NCT02395471)
NCT ID: NCT02395471
Last Updated: 2019-07-30
Results Overview
The first primary objective of the study was to assess the acceptability of a novel, minimally invasive esophageal mucosal sampling technique, the Cytosponge™, in subjects undergoing surveillance of BE who have had at least a C1 or M3 segment confirmed, and 2) in subjects with GERD undergoing screening for BE. This includes measures of acceptability as demonstrated on the Impact of Event Scale, a Visual Analog Scale for Pain, and the subject's willingness to undergo repeat Cytosponge™ administration if it were offered to him/her. The Visual Analog Scale is measured from 0-100 scale for pain, 0 representing no pain and 100 representing the highest level of pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
191 participants
Primary outcome timeframe
Immediately post procedure up to 7 days +/- 3 days
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Patient Wth Barrett's
Subjects presenting for routine endoscopic BE surveillance examinations
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
62
|
|
Overall Study
COMPLETED
|
122
|
59
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Patient Wth Barrett's
Subjects presenting for routine endoscopic BE surveillance examinations
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Failure to swollow sponge twice
|
1
|
0
|
|
Overall Study
Patient did not return for procedure
|
0
|
1
|
|
Overall Study
Subject not eligible
|
1
|
0
|
Baseline Characteristics
Cytosponge Adequacy Study Evaluation II
Baseline characteristics by cohort
| Measure |
Patient Wth Barrett's
n=129 Participants
Subjects presenting for routine endoscopic BE surveillance examinations
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Patients With GERD
n=62 Participants
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
127 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysThe first primary objective of the study was to assess the acceptability of a novel, minimally invasive esophageal mucosal sampling technique, the Cytosponge™, in subjects undergoing surveillance of BE who have had at least a C1 or M3 segment confirmed, and 2) in subjects with GERD undergoing screening for BE. This includes measures of acceptability as demonstrated on the Impact of Event Scale, a Visual Analog Scale for Pain, and the subject's willingness to undergo repeat Cytosponge™ administration if it were offered to him/her. The Visual Analog Scale is measured from 0-100 scale for pain, 0 representing no pain and 100 representing the highest level of pain.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=191 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
On scale of 0-10 (10-high), rate Cytosponge exper.
|
7.2 Units on a scale
Standard Deviation 2.5
|
—
|
—
|
—
|
|
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
On scale of 0-10 (10-high), rate endoscopy exper.
|
8.5 Units on a scale
Standard Deviation 2.5
|
—
|
—
|
—
|
|
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
Diff. between the two scales: (Cyto/Endoscop)
|
-1.3 Units on a scale
Standard Deviation 2.4
|
—
|
—
|
—
|
|
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
Visual Analog Scale
|
16.2 Units on a scale
Standard Deviation 18.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysTo assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=127 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
n=61 Participants
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Number of Participants With Adequate Cytosponge™ Sample
|
115 Participants
|
56 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysThe operating characteristics of this technique against a gold standard of upper endoscopy with biopsies for endoscopic surveillance in subjects with BE who demonstrate an adequate sample on Cytosponge assessment.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=154 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Operating Characteristics
Sensitivity
|
75.5 Percentage
Interval 65.6 to 83.8
|
—
|
—
|
—
|
|
Operating Characteristics
Specificity
|
76.7 Percentage
Interval 64.0 to 86.6
|
—
|
—
|
—
|
|
Operating Characteristics
Positive Predictive Value
|
83.5 Percentage
Interval 73.9 to 90.7
|
—
|
—
|
—
|
|
Operating Characteristics
Accuracy
|
76 Percentage
Interval 68.4 to 82.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysThe second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=158 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Sensitivity
|
77 Percentage
Interval 67.5 to 84.8
|
—
|
—
|
—
|
|
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Specificity
|
81 Percentage
Interval 68.6 to 90.1
|
—
|
—
|
—
|
|
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Positive Predictive Value
|
87.5 Percentage
Interval 78.7 to 93.6
|
—
|
—
|
—
|
|
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Negative Predictive Value
|
67.1 Percentage
Interval 54.9 to 77.9
|
—
|
—
|
—
|
|
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Accuracy
|
78.5 Percentage
Interval 71.2 to 84.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysPopulation: Among study subjects with BE that exhibited HGD, there were no true negatives or false positives, therefore specificity of the assay was not calculated for this subgroup.
The third secondary objective was to assess the operating characteristics of Cytosponge™ as a function of baseline histology. At the outset of this study, no data was available regarding the accuracy of TFF3 in samples collected by Cytosponge™ in subjects with BE and more advanced disease (low-grade dysplasia and high-grade dysplasia). These subjects are at greatest risk for progression to cancer. We planned to collect pilot data on operating characteristics of the assay by degree of baseline dysplasia. We hypothesized that TFF3 would perform with similar operating characteristics in this group compared to non-dysplastic BE.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=77 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
n=13 Participants
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
n=10 Participants
Low Grade Dysplasia
|
High Grade Dysplasia
n=6 Participants
High Grade Dysplasia
|
|---|---|---|---|---|
|
Cytosponge™ Operating Characteristics as a Function of Baseline Histology
Sensitivity
|
76.2 Percentage
|
66.7 Percentage
|
77.8 Percentage
|
83.3 Percentage
|
|
Cytosponge™ Operating Characteristics as a Function of Baseline Histology
Specificity
|
64.3 Percentage
|
100 Percentage
|
0 Percentage
|
NA Percentage
Analysis not available, See Population Description.
|
|
Cytosponge™ Operating Characteristics as a Function of Baseline Histology
Accuracy
|
74.0 Percentage
|
69.2 Percentage
|
70.0 Percentage
|
83.3 Percentage
|
SECONDARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysThe fourth secondary objective was to assess the degree of mucosal abrasion following Cytosponge™ administration, using a standardized scale. The incidence is presented in the data below for abrasion, bleeding and perforation observed during Endoscopy.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=190 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Abrasion
|
117 Participants
|
—
|
—
|
—
|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Bleeding
|
58 Participants
|
—
|
—
|
—
|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Bleeding-From Cytosponge contact site
|
14 Participants
|
—
|
—
|
—
|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Bleeding-From Biopsy Site
|
56 Participants
|
—
|
—
|
—
|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Perforation
|
0 Participants
|
—
|
—
|
—
|
|
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Any of These 3 Conditions
|
141 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately post procedure up to 7 days +/- 3 daysTo collect and analyze ongoing safety measures of Cytosponge use in the target population.
Outcome measures
| Measure |
Study Participant Cytosponge Procedure Acceptability
n=14 Participants
Acceptability of the Cytosponge Procedure by all study subjects that underwent both Cytosponge and Endoscopy
|
Patients With GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Low Grade Dysplasia
Low Grade Dysplasia
|
High Grade Dysplasia
High Grade Dysplasia
|
|---|---|---|---|---|
|
Ongoing Safety Measures
Throat Irritation
|
2 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Not Coded
|
3 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Dyspepsia
|
1 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Vomiting
|
1 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Chest Discomfort
|
1 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Device Breakage
|
2 Participants
|
—
|
—
|
—
|
|
Ongoing Safety Measures
Oropharyngeal Pain
|
4 Participants
|
—
|
—
|
—
|
Adverse Events
Patient Wth Barrett's
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Patients With GERD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient Wth Barrett's
n=129 participants at risk
Subjects presenting for routine endoscopic BE surveillance examinations who had at least a C1 or M3 segment confirmed (or medically suspected).
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Patients With GERD
n=62 participants at risk
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
|---|---|---|
|
Product Issues
Sponge Detachment
|
1.6%
2/129 • Number of events 2 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
0.00%
0/62 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
Other adverse events
| Measure |
Patient Wth Barrett's
n=129 participants at risk
Subjects presenting for routine endoscopic BE surveillance examinations who had at least a C1 or M3 segment confirmed (or medically suspected).
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
Patients With GERD
n=62 participants at risk
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing screening for BE
Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
2/129 • Number of events 2 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
3.2%
2/62 • Number of events 2 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.78%
1/129 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
1.6%
1/62 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/129 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
1.6%
1/62 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/129 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
1.6%
1/62 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
Product Issues
Device Breakage
|
1.6%
2/129 • Number of events 2 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
0.00%
0/62 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
General disorders
Chest Discomfort
|
0.78%
1/129 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
0.00%
0/62 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
|
Investigations
Not Coded
|
1.6%
2/129 • Number of events 2 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
1.6%
1/62 • Number of events 1 • Subjects will be contacted 7 days (+/- 2 days) following the Cytosponge and upper endoscopy procedures. During this phone call, adverse events will be assessed and subjects will complete questionnaires. Participation in the study is complete when subjects have completed the follow-up phone call.
|
Additional Information
Dr.Jaime Kean
Medtronic MITG Gastrointestinal & Hepatology
Phone: 303-882-6759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place