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Photoacoustic Endoscopy of Barrett's Esophagus

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The Washington University

Status and phase

Completed
Early Phase 1

Conditions

Barrett Esophagus

Treatments

Procedure: Endoscopic surgery (standard of care)
Procedure: Photoacoustic endoscopy
Procedure: Endoscopic ultrasound (standard of care)

Study type

Interventional

Funder types

Other

Identifiers

NCT02606292
201204145

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Arm 1: PAE assessment
Experimental group
Description:
-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.
Treatment:
Procedure: Endoscopic surgery (standard of care)
Procedure: Endoscopic ultrasound (standard of care)
Procedure: Photoacoustic endoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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