Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | The primary endpoint will be the number of subjects achieving completed VLE imaging studies at the time of EDG. | The research participants will be followed and evaluated for the duration of their VLE procedure, an expected average of 10 additional minutes beyond the standard EDG procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD) for suspected or confirmed Barrett's esophagus (BE)or for non-BE related conditions other than esophageal varices.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herbert C. Wolfsen, MD | Mayo Clinic | Study Chair |
| Prateek Sharma, MD | University Medical Center, Kansas City, MO | Principal Investigator |
| Kenneth Wang, MD | Mayo Clinic, Rochester, MN | Principal Investigator |
| Herbert C Wolfsen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic |
Not provided
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Rochester |
| Massachusetts |
| 55905 |
| United States |
| VA Medical Center | Kansas City | Missouri | 64128 | United States |
| D004066 |
| Digestive System Diseases |