Undergoing Esophagogastroduodenoscopy (EGD)NCT02031900
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
An observational study of Undergoing Esophagogastroduodenoscopy (EGD), run by NinePoint Medical at 1 site in United States.
Trial summary
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 Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Undergoing Esophagogastroduodenoscopy (EGD)
- What is being tested?
- NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD).
Who may be able to join
- 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, are willing to take a pregnancy test.
Who cannot join
- Patients on anticoagulation undergoing high risk procedures in accordance to 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 prohibit full distention of the balloon from the NvisionVLE catheter.
- Patients with known eosinophilic esophagitis.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.
- Being tested
- NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory KitDevice
The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.
| Study group | Role | What they receive |
|---|---|---|
| Undergoing EGD | Not described Receives: Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Achieving a VLE image is defined as completing a full 6cm scan. This will be presented as a percentage of patients.
Measured: 1 day
Secondary outcomes (1)
The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undergoing Esophagogastroduodenoscopy (EGD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NinePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prashanthi Thota, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031900
- Sponsor's protocol ID
- 13-01
- Status last verified
- Mar 2014
- First submitted
- 7 Jan 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
- ClinicalTrials.gov ID
- NCT02031900
- Acronym / sponsor ID
- 13-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NinePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergoing EGD | – | Device: NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females >18 years of age undergoing esophagogastroduodenoscopy (EGD).
Key inclusion criteria (4 listed)
- 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, are willing to take a pregnancy test.
Key exclusion criteria (9 listed)
- Patients on anticoagulation undergoing high risk procedures in accordance to 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 prohibit full distention of the balloon from the NvisionVLE catheter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory KitThe NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization. | Device | Undergoing EGD |
Primary outcome
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: 1 day
Achieving a VLE image is defined as completing a full 6cm scan. This will be presented as a percentage of patients.
1 secondary outcome
The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashanthi Thota, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undergoing Esophagogastroduodenoscopy (EGD), run by NinePoint Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.