Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

Study Overview
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Brief Summary
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The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .

Detailed Description
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Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm). It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.

Official Title
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Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Device: Optical Frequency Domain Imaging (OFDI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over the age of 18, capable of giving informed consent, are undergoing elective EGD, and if female are willing to take a pregnancy test Exclusion Criteria: patients on oral anticoagulation medications, with a history of hemostasis disorders and patients that are pregnant
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Frequency Domain imaging System<br>Optical Frequency Domain Imaging (OFDI) balloon based imaging | Device: Optical Frequency Domain Imaging (OFDI)<br>* Optical Frequency Domain (OFDI) imaging of esophagus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening | Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy. | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's, esophagus, OCT, imaging