Barrett's Esophagus
Conditions
Keywords
Barrett's Esophagus, Esophagus, OCT, Imaging, Radiofrequency Ablation, BARRX
Brief summary
The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
Detailed description
This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits. Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (\ 5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol. Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.
Interventions
DEVICEMGH OFDI Imaging
Imaging of Esophagus with OFDI system
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of Barrett's esophagus * Patients undergoing an Esophagogastroduodenoscopy (EGD) * Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation * Patients must be over the age of 18 * Patient must be able to give informed consent * Women with child bearing potential must have a negative pregnancy test prior to procedure
Exclusion criteria
* Patients on oral anticoagulation medications * Patients with a history of hemostasis disorders * Patients that are pregnant * Patients with esophageal strictures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions | During the OFDI imaging session (about 5 minutes) | Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MGH OFDI Imaging OFDI imaging
MGH OFDI Imaging: Imaging of Esophagus with OFDI system | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | MGH OFDI Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
Time frame: During the OFDI imaging session (about 5 minutes)
Population: A total of 17 Participants took place in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feasibility | Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions | Imaging sessions with successful OFDI imaging | 64 Imaging sessions |
| Feasibility | Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions | Imaging session w/ OFDI & corresponding pathology | 29 Imaging sessions |