Cytosponge Adequacy Study Evaluation II (CASEII)

• ClinicalTrials.gov Identifier: NCT02395471
• Recruitment Status: Completed
• First Posted: March 23, 2015
• Results First Posted: July 30, 2019
• Last Update Posted: July 30, 2019
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

Brief Summary:

This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.

Condition or disease	Intervention/treatment	Phase
Barrett's Esophagus; GERD	Device: Cytosponge™ Cell Collection Device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 191 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients With Barrett's Esophagus or GERD Symptoms
• Study Start Date: August 2015
• Actual Primary Completion Date: April 24, 2018
• Actual Study Completion Date: June 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patient wth Barrett's; Subjects presenting for routine endoscopic BE surveillance examinations	Device: Cytosponge™ Cell Collection Device; Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Experimental: Patients with GERD; Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE	Device: Cytosponge™ Cell Collection Device; Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Outcome Measures

Primary Outcome Measures :

1. Procedure Preference and Acceptability Questionnaire and Visual Analog Scale [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   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.
2. Number of Participants With Adequate Cytosponge™ Sample [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   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 :

1. Operating Characteristics [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   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.
2. Cytosponge™ Operating Characteristics vs Worst Histology Ever [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.
3. Cytosponge™ Operating Characteristics as a Function of Baseline Histology [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   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.
4. Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   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.
5. Ongoing Safety Measures [ Time Frame: Immediately post procedure up to 7 days +/- 3 days ]
   To collect and analyze ongoing safety measures of Cytosponge use in the target population.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Male or female subjects, age 18 and above.
2. Able to read, comprehend, and complete the consent form.
3. Clinically fit for an endoscopy.
4. 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:

1. Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia.
2. Any history of esophageal varices, stricture, or prior dilation of the esophagus.
3. 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.
4. Known bleeding disorder.
5. Individuals who have had a myocardial infarction or any cardiac event < 6 months prior to enrollment.
6. Individuals who have had a cerebrovascular event < 6 months prior to enrollment in which swallowing was affected.
7. Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies.
8. Any history of esophageal surgery, except for uncomplicated fundoplication.
9. Do not need upper endoscopy as part of patient management.
10. Pregnancy

Contacts and Locations

Locations

United States, California

Univeristy of California, Los Angeles

Los Angeles, California, United States, 90095

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599-7080

United States, Tennessee

Gastrointestinal Associates

Knoxville, Tennessee, United States, 37909

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Study Director: Amanda Cafaro, BSN; Medtronic Clinical Research Director

  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Study Protocol  [PDF] December 1, 2017

Statistical Analysis Plan  [PDF] August 20, 2018

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02395471
• Other Study ID Numbers: B-271
• First Posted: March 23, 2015
• Results First Posted: July 30, 2019
• Last Update Posted: July 30, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Barrett Esophagus; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases