Back to resultsCytosponge Adequacy Study Evaluation II (CASEII)
Primary Purpose
Barrett's Esophagus, GERD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosponge™ Cell Collection Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett's Esophagus
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects, age 18 and above.
- Able to read, comprehend, and complete the consent form.
- Clinically fit for an endoscopy.
- a) Previous confirmed diagnosis of Barrett's esophagus with intestinal metaplasia, and Prague classification of at least one circumferential centimeter of BE or a total BE segment length of at least 3 centimeters (C1+ or CXM3+) (BE arm) . OR b) If the subject does not have documented Prague Classification prior to screening, but the PI is convinced that the subject will meet the inclusion criteria based on previous documentation (for instance, mention of "long-segment BE," they may enroll the subject in the study at their discretion. The study upper endoscopy must confirm that the subject has C1+ or CXM3+ (BE arm). If (C1+ or CXM3+) is not observed at the time of study endoscopy, the subject may still be enrolled but not included in the data analysis with the BE cohort. The data may be analyzed in a separate cohort. OR c) Self-reported heartburn or regurgitation on at least a monthly basis for at least 6 months (GERD arm).
Exclusion Criteria:
- Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia.
- Any history of esophageal varices, stricture, or prior dilation of the esophagus.
- Current use of anti-thrombotics (anti-coagulants and anti-platelet drugs) that cannot be safely discontinued for the appropriate drug-specific interval in the peri-administration period. Depending on the particular agent or reason for the anti-thrombotic therapy, it may not be necessary to discontinue anti-thrombotic agents. There could be circumstances where the drug may not need to be discontinued if the risk of bleeding is considered negligible (e.g. daily aspirin therapy). Physicians should use their clinical judgement and should consult guidelines such as those provided by the ASGE.
- Known bleeding disorder.
- Individuals who have had a myocardial infarction or any cardiac event < 6 months prior to enrollment.
- Individuals who have had a cerebrovascular event < 6 months prior to enrollment in which swallowing was affected.
- Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies.
- Any history of esophageal surgery, except for uncomplicated fundoplication.
- Do not need upper endoscopy as part of patient management.
- Pregnancy
Sites / Locations
- Univeristy of California, Los Angeles
- University of Colorado
- Northwestern University
- University of North Carolina
- Gastrointestinal Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient wth Barrett's
Patients with GERD
Arm Description
Subjects presenting for routine endoscopic BE surveillance examinations
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Outcomes
Primary Outcome Measures
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
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.
Number of Participants With Adequate Cytosponge™ Sample
To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.
Secondary Outcome Measures
Operating Characteristics
The 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.
Cytosponge™ Operating Characteristics vs Worst Histology Ever
The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.
Cytosponge™ Operating Characteristics as a Function of Baseline Histology
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.
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
The 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.
Ongoing Safety Measures
To collect and analyze ongoing safety measures of Cytosponge use in the target population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02395471
Brief Title
Cytosponge Adequacy Study Evaluation II
Acronym
CASEII
Official Title
Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients With Barrett's Esophagus or GERD Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.
Detailed Description
This is a cross-sectional study of subjects with Barrett's esophagus (BE) to assess the utility of the Cytosponge device as a non-endoscopic method for collecting surface cells from the esophagus. This study will enroll 2 groups of subjects: 1) Subjects presenting for routine endoscopic BE surveillance examinations (n=120), and 2) Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE (n=55). After informed consent, and on the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge device and complete a questionnaire. The subject will then undergo routine upper endoscopy, with assessment of BE (where applicable), and biopsy per accepted surveillance or screening recommendations. The Cytosponge will be placed in fixative and shipped to an accredited pathology laboratory for embedding in paraffin and hematoxylin and eosin (H&E) staining to assess the adequacy of the specimen. Further evaluation of the specimen may be performed using trefoil factor 3 (TFF3). If the Cytosponge tissue specimen is inadequate, the subject will be recalled for a repeat sponge procedure (not endoscopy) 30 days later. Routine care tissue biopsies will undergo standard processing and H&E staining at the home institution, with assessment by expert gastrointestinal pathologists. Subjects will be contacted via phone 7 days (+/- 2 days) after Cytosponge administration to complete additional questionnaires and assess adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, GERD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient wth Barrett's
Arm Type
Experimental
Arm Description
Subjects presenting for routine endoscopic BE surveillance examinations
Arm Title
Patients with GERD
Arm Type
Experimental
Arm Description
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Intervention Type
Device
Intervention Name(s)
Cytosponge™ Cell Collection Device
Intervention Description
Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Primary Outcome Measure Information:
Title
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
Description
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.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Title
Number of Participants With Adequate Cytosponge™ Sample
Description
To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Secondary Outcome Measure Information:
Title
Operating Characteristics
Description
The 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.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Title
Cytosponge™ Operating Characteristics vs Worst Histology Ever
Description
The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Title
Cytosponge™ Operating Characteristics as a Function of Baseline Histology
Description
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.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Title
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy
Description
The 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.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
Title
Ongoing Safety Measures
Description
To collect and analyze ongoing safety measures of Cytosponge use in the target population.
Time Frame
Immediately post procedure up to 7 days +/- 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, age 18 and above.
Able to read, comprehend, and complete the consent form.
Clinically fit for an endoscopy.
a) Previous confirmed diagnosis of Barrett's esophagus with intestinal metaplasia, and Prague classification of at least one circumferential centimeter of BE or a total BE segment length of at least 3 centimeters (C1+ or CXM3+) (BE arm) . OR b) If the subject does not have documented Prague Classification prior to screening, but the PI is convinced that the subject will meet the inclusion criteria based on previous documentation (for instance, mention of "long-segment BE," they may enroll the subject in the study at their discretion. The study upper endoscopy must confirm that the subject has C1+ or CXM3+ (BE arm). If (C1+ or CXM3+) is not observed at the time of study endoscopy, the subject may still be enrolled but not included in the data analysis with the BE cohort. The data may be analyzed in a separate cohort. OR c) Self-reported heartburn or regurgitation on at least a monthly basis for at least 6 months (GERD arm).
Exclusion Criteria:
Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia.
Any history of esophageal varices, stricture, or prior dilation of the esophagus.
Current use of anti-thrombotics (anti-coagulants and anti-platelet drugs) that cannot be safely discontinued for the appropriate drug-specific interval in the peri-administration period. Depending on the particular agent or reason for the anti-thrombotic therapy, it may not be necessary to discontinue anti-thrombotic agents. There could be circumstances where the drug may not need to be discontinued if the risk of bleeding is considered negligible (e.g. daily aspirin therapy). Physicians should use their clinical judgement and should consult guidelines such as those provided by the ASGE.
Known bleeding disorder.
Individuals who have had a myocardial infarction or any cardiac event < 6 months prior to enrollment.
Individuals who have had a cerebrovascular event < 6 months prior to enrollment in which swallowing was affected.
Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies.
Any history of esophageal surgery, except for uncomplicated fundoplication.
Do not need upper endoscopy as part of patient management.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Cafaro, BSN
Organizational Affiliation
Medtronic Clinical Research Director
Official's Role
Study Director
Facility Information:
Facility Name
Univeristy of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Gastrointestinal Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cytosponge Adequacy Study Evaluation II
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