- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606292
Photoacoustic Endoscopy of Barrett's Esophagus
Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.
The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 years and older.
- Patients with Barrett's esophagus scheduled for esophageal surgery.
- Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
- Subjects must be able to understand and willing to sign a written informed consent form.
Exclusion Criteria:
- Inability to give informed consent.
- Pregnancy.
- Age less than 18 years
- Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
- Acute GI bleeding.
- Coagulopathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: PAE assessment
-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
Time Frame: Day 1
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-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system.
The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
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Day 1
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Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy
Time Frame: Day 1
|
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system.
The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
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Day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Bryan F Meyers, M.D., M.P.H., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201204145
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.
Clinical Trials on Barrett Esophagus
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedTerminatedBarrett's Esophagus | High-grade Dysplasia in Barrett Esophagus | Low Grade Dysplasia in Barrett EsophagusUnited States
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University Medical Center GroningenCompletedEsophageal Cancer | Barrett Esophagus | Dysplasia in Barrett EsophagusNetherlands
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Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedBarrett Esophagus | Barrett AdenocarcinomaNetherlands
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Mayo ClinicTerminatedBarretts Esophagus With High Grade Dysplasia | Barrett AdenocarcinomaUnited States
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Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina... and other collaboratorsNot yet recruitingEsophageal Cancer | Barrett Adenocarcinoma | Barretts Esophagus With Dysplasia
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Portsmouth Hospitals NHS TrustUniversity of PortsmouthUnknownBarrett Esophagus | Barrett Adenocarcinoma | Barrett Metaplasia | Barrett Oesophagitis With DysplasiaUnited Kingdom
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Professor Michael BourkeWithdrawn
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Lucid Diagnostics, Inc.RecruitingBarrett Esophagus | Barretts Esophagus With Dysplasia | Esophagus AdenocarcinomaUnited States
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Allegheny Singer Research Institute (also known...Integra LifeSciences CorporationTerminatedBarrett Esophagus | High Grade Dysplasia | EsophagusUnited States
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