The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus

NCT01084629 | Completed

• 1 other identifier: 07-006981
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa post ablation and to assess the ability of the Fujinon FICE system to detect this, as compared to white light endoscopy. A subgroup will also be compared with laser confocal microscopy

Conditions

Barrett's Esophagus

Keywords

Barrett's Esophagus; Surveillance

Outcome Measures

Primary Outcomes (1)

• detection of dysplasic areas

  Areas of residual mucosa will be scored for being present, absent or suspicious. The ability of both FICE and white light endoscopy to find areas will be graded on the number of areas found, and the size of the areas estimated at the time of endoscopy

  during surveillance endoscopy

Study Arms (2)

Surveillance Barrett's esophagus

Patients scheduled for endoscopic surveillance of Barrett's esophagus

Barrett's esophagus post ablation

Patients scheduled for surveillance endoscopy who have undergone ablative therapies (PDT, RF ablation) for their Barrett's esophagus

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Barrett's esophagus

You may qualify if:

• Visible Barrett's esophagus
• Scheduled for Surveillance Endoscopy
• Able to undergo endoscopy

You may not qualify if:

• Unable to undergo endoscopy
• Unable to stop blood thinning medications

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth K Wang, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kathy and Russ Van Cleve Professor of Gastroenterology Research

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: November 1, 2010
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

US (1)