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

Not Applicable

Completed

• Conditions: Barrett's Esophagus
• Interventions: Device: Optical Frequency Domain Imaging (OFDI)

• Registration Number: NCT01401699
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2011-11-16
• Study Completion: 2011-11-16
• Results First Submitted: 2018-07-27
• Results First Submitted QC: 2018-09-26
• Results First Posted: 2018-09-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Frequency Domain imaging System	Optical Frequency Domain Imaging (OFDI)	Optical Frequency Domain Imaging (OFDI) balloon based imaging

Primary Outcome Measures

Name	Time	Method
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening	Images will be acquired during the OFDI imaging session which should take an average of 5 minutes	Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.

Trial Locations

Locations (1)

Massachussetts General Hospital; 🇺🇸 Boston, Massachusetts, United States