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

NCT ID: NCT01401699

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-11-16

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.

Conditions

Barrett's Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Optical Frequency Domain imaging System

Optical Frequency Domain Imaging (OFDI) balloon based imaging

Group Type: EXPERIMENTAL

Optical Frequency Domain Imaging (OFDI)

Intervention Type: DEVICE

Optical Frequency Domain (OFDI) imaging of esophagus

Interventions

Optical Frequency Domain Imaging (OFDI)

Optical Frequency Domain (OFDI) imaging of esophagus

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Norman Nishioka, MD

Role: PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Locations

Massachussetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R21CA141884

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2006-P-000203

Identifier Type: -

Identifier Source: org_study_id