- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01844921
High Resolution Optical Imaging of the Esophagus Using the Nvision Volumetric Laser Endomicroscopy (VLE™) Imaging System
May 16, 2013 updated by: NinePoint Medical
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
This is a single center, single arm, open label observational trial of patients undergoing EGD.
The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE catheter to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD).
Description
Inclusion Criteria:
- Males and females over the age of 18 years.
- Patients presenting for an EGD.
- Ability to provide written, informed consent.
- Females who are able to become pregnant, and are willing to take a pregnancy test.
Exclusion Criteria:
- Patients on anticoagulation undergoing high risk procedures in accordance to American Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
- Patients with esophageal varices that preclude biopsies.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
- Patients with known eosinophilic esophagitis.
- Patients that are pregnant.
Patients with a history of hemostasis disorders**.
- Patients on anticoagulation undergoing low risk procedures are not excluded. **Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus.
Time Frame: Day of procedure
|
Achieving a VLE image is defined as completing a full 6cm scan.
This will be presented as a percentage of patients.
|
Day of procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.
Time Frame: Day of procedure.
|
Procedural workflow and physician interface to the console will be assessed by a questionnaire that will be completed by the investigational staff involved in the procedure (eg - Were you (physician) able to position the catheter in the desired position?).
|
Day of procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Poneros, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
April 22, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (ESTIMATE)
May 3, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
May 17, 2013
Last Update Submitted That Met QC Criteria
May 16, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 12_02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Undergoing Esophagogastroduodenoscopy (EGD)
-
NinePoint MedicalCompletedUndergoing Esophagogastroduodenoscopy (EGD)United States
-
Yu-Hsi hsiehUnknownPatients Undergoing Diagnostic EGDTaiwan
-
Dalin Tzu Chi General HospitalCompletedPatients Undergoing Diagnostic EGDTaiwan
-
Saneso Inc.West Virginia UniversityCompleted
-
Dalin Tzu Chi General HospitalCompletedEsophagogastroduodenoscopyTaiwan
-
Yonsei UniversityCompletedEGD ProcedureKorea, Republic of
-
Mineto KamataCompletedEsophagogastroduodensocopy (EGD) ProcedureUnited States
-
Bispebjerg HospitalEnrolling by invitationEsophagogastroduodenoscopy | Anesthetics, LocalDenmark
-
NinePoint MedicalCompleted
-
Affiliated Hospital to Academy of Military Medical...UnknownEsophagogastroduodenoscopyChina