Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients With Barrett's Esophagus or GERD Symptoms

Status: Completed
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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).

Locations
United States
California
Univeristy of California, Los Angeles
Los Angeles
Colorado
University of Colorado
Aurora
Illinois
Northwestern University
Chicago
North Carolina
University of North Carolina
Chapel Hill
Tennessee
Gastrointestinal Associates
Knoxville
Time Frame
Start Date: August 2015
Completion Date: June 1, 2018
Participants
Target number of participants: 191
Treatments
Experimental: Patient wth Barrett's
Subjects presenting for routine endoscopic BE surveillance examinations
Experimental: Patients with GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
Related Therapeutic Areas
Sponsors
Leads: Medtronic - MITG

This content was sourced from clinicaltrials.gov

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