Barrett's Esophagus
Conditions
Keywords
Barrett's, esophagus, OCT, imaging
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.
Interventions
DEVICEOptical Frequency Domain Imaging (OFDI)
Optical Frequency Domain (OFDI) imaging of esophagus
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Optical Frequency Domain Imaging System OFDI imaging
Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus | 109 |
| Total | 109 |
Baseline characteristics
| Characteristic | Optical Frequency Domain Imaging System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 109 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 109 |
| other Total, other adverse events | 0 / 109 |
| serious Total, serious adverse events | 0 / 109 |
Outcome results
Primary
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.
Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Population: All subjects completed the study with no adverse events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Frequency Domain Imaging | Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening | 109 Participants |