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

Phase 1
Open (Enrolling)
Barrett's Esophagus

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and specificity of OFDI imaging

Outcome Description:

Images will be analyzed and compared to standard of care biopsy

Outcome Time Frame:

Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Safety Issue:


Principal Investigator

Guillermo Tearney, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachussetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

December 2012

Related Keywords:

  • Barrett's Esophagus
  • Barrett's
  • esophagus
  • OCT
  • imaging
  • Barrett Esophagus



Massachussetts General Hospital Boston, Massachusetts  02114