Photoacoustic Endoscopy of Barrett's Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Barrett Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Photoacoustic endoscopy

Intervention Type PROCEDURE

Endoscopic ultrasound (standard of care)

Intervention Type PROCEDURE

Endoscopic surgery (standard of care)

Intervention Type PROCEDURE

Interventions

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Photoacoustic endoscopy

Intervention Type PROCEDURE

Endoscopic ultrasound (standard of care)

Intervention Type PROCEDURE

Endoscopic surgery (standard of care)

Intervention Type PROCEDURE

Other Intervention Names

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PAE EUS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No