Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

Mass General Brigham

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: Optical Frequency Domain Imaging (OFDI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01401699

2006-P-000203

5R21CA141884 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .

Full description

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.

Enrollment: 109 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

Optical Frequency Domain imaging System

Experimental group

Description:

Optical Frequency Domain Imaging (OFDI) balloon based imaging

Treatment:

Device: Optical Frequency Domain Imaging (OFDI)