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NCT01084629 Clinical Trial

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

Barrett's Esophagus Clinical Trial

Official title:
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) for the Detection of Dysplasia in Barrett's Esophagus and in Post Ablation Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01084629
Other study ID # 07-006981
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date November 4, 2016

Study information
Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date November 4, 2016
Est. primary completion date November 4, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Visible Barrett's esophagus - Scheduled for Surveillance Endoscopy - Able to undergo endoscopy Exclusion Criteria: - Unable to undergo endoscopy - Unable to stop blood thinning medications

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
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Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
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Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A

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