Cytosponge Adequacy Study Evaluation II

NCT02395471 | Completed Results FDA Device

• 1 other identifier: B-271
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Barrett's Esophagus; GERD

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately post procedure up to 7 days +/- 3 days

• 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.

  Immediately post procedure up to 7 days +/- 3 days

Secondary Outcomes (5)

• Operating Characteristics

  Immediately post procedure up to 7 days +/- 3 days

• Cytosponge™ Operating Characteristics vs Worst Histology Ever

  Immediately post procedure up to 7 days +/- 3 days

• Cytosponge™ Operating Characteristics as a Function of Baseline Histology

  Immediately post procedure up to 7 days +/- 3 days

• Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy

  Immediately post procedure up to 7 days +/- 3 days

• Ongoing Safety Measures

  Immediately post procedure up to 7 days +/- 3 days

Study Arms (2)

Patient wth Barrett's

EXPERIMENTAL

Subjects presenting for routine endoscopic BE surveillance examinations

Device: Cytosponge™ Cell Collection Device

Patients with GERD

EXPERIMENTAL

Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE

Device: Cytosponge™ Cell Collection Device

Interventions

Cytosponge™ Cell Collection Device DEVICE

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Patient wth Barrett's; Patients with GERD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age 18 and above.
• Able to read, comprehend, and complete the consent form.
• Clinically fit for an endoscopy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (5)

Univeristy of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of North Carolina

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

Location

Gastrointestinal Associates

Knoxville, Tennessee, 37909, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Results Point of Contact

• Title: Dr.Jaime Kean
• Organization: Medtronic MITG Gastrointestinal & Hepatology

Jaime.M.Kean@medtronic.com

303-882-6759

Study Officials

• Amanda Cafaro, BSN

  Medtronic Clinical Research Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 23, 2015
• Study Start: August 1, 2015
• Primary Completion: April 24, 2018
• Study Completion: June 1, 2018
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)