- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670134
Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).
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Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade <B, C, and D)
Exclusion Criteria:
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anti-coagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Volumetric laser Endomicroscopy (VLE)
Volumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE Imaging System.
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Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe.
The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel.
Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time Frame: 1 year
|
Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease.
Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
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1 year
|
Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time Frame: 1 year
|
Measure the distribution (gastric cardia versus esophagus) of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease.
Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
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1 year
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Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
Time Frame: 1 year
|
Measure the thickness of neosquamous epithelium (mm) with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease.
Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment
Time Frame: 3 years
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The proposed model will stratify patients into two categories (1) low risk of recurrence and (2) high risk of recurrence.
Low risk of disease recurrence is defined by a rate of <5% per patient-year.
High risk of disease recurrence is defined by a rate of >10% per patient year.
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cadman L Leggett, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-003333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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