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Trial record 16 of 226 for:    "Barrett syndrome"

Photoacoustic Endoscopy of Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT02606292
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Barrett Esophagus Procedure: Photoacoustic endoscopy Procedure: Endoscopic ultrasound (standard of care) Procedure: Endoscopic surgery (standard of care) Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Photoacoustic Endoscopy of Barrett's Esophagus
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.
Procedure: Photoacoustic endoscopy
Other Name: PAE

Procedure: Endoscopic ultrasound (standard of care)
Other Name: EUS

Procedure: Endoscopic surgery (standard of care)



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606292


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Bryan F Meyers, M.D., M.P.H. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02606292     History of Changes
Other Study ID Numbers: 201204145
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases