Skip to main content
OpenTrials
Completed

NCT Number: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photoacoustic endoscopy

Procedure

Other names: PAE

Endoscopic ultrasound (standard of care)

Procedure

Other names: EUS

Endoscopic surgery (standard of care)

Procedure

Primary outcomes

  1. 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

    -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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.