EsophagogastroduodenoscopyNCT02215291
NvisionVLE™ Registry System Registry
An observational study of Esophagogastroduodenoscopy, run by NinePoint Medical at 18 sites in United States.
Trial summary
Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagogastroduodenoscopy
- How many people
- 1,000 participants
- Where
- 18 sitesUnited States
- Study dates
- Jul 2014to Jan 2018
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 20 sites; each site will have the opportunity to enroll up to 100 patients. There will be up to 1000 patients enrolled in the registry.
Who may be able to join
- Patients presenting for an endoscopic examination of the esophagus
- Ability to provide written, informed consent to participate in the Registry
Who cannot join
- Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
VA Boston Health Care System
Boston, Massachusetts, 02132
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Chicago Medical Center
Chicago, Illinois, 60637
Methodist Dallas Medical Center
Dallas, Texas, 75203
Geisinger
Danville, Pennsylvania, 17821
Mayo Clinic
Jacksonville, Florida, 32224
Ochsner Health System
Kenner, Louisiana, 70121
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
North Shore/ LIJ
Long Island City, New York, 11030
University of Southern California
Los Angeles, California, 90033
Univeristy of South Alabama
Mobile, Alabama, 36688
Weill Cornell Medical College/NewYork-Presbyterian Hospital
New York, New York, 10021
Columbia Univeristy
New York, New York, 10032
University of California Irvine
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32803
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry
Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.
Read the detailed description
This is a prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.
Up to 1000 patients from up to 20 sites nationwide.
There are no protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening examination may not require additional screening endoscopies. For patients with established disease, further surveillance endoscopies will vary based on the extent of the disease (e.g. every 3 months, every 6 months, annual), which is based on the following American Society for Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing EGD or esophagoscopy | The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician
No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Percent of patients with histologically confirmed disease and a breakdown of diseases observed
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- NinePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Smith, MD, MBA, Principal investigator, Temple University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215291
- Sponsor's protocol ID
- 13_02
- Status last verified
- Mar 2018
- First submitted
- 31 Jul 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith MS, Cash B, Konda V, Trindade AJ, Gordon S, DeMeester S, Joshi V, Diehl D, Ganguly E, Mashimo H, Singh S, Jobe B, McKinley M, Wallace M, Komatsu Y, Thakkar S, Schnoll-Sussman F, Sharaiha R, Kahaleh M, Tarnasky P, Wolfsen H, Hawes R, Lipham J, Khara H, Pleskow D, Navaneethan U, Kedia P, Hasan M, Sethi A, Samarasena J, Siddiqui UD, Gress F, Rodriguez R, Lee C, Gonda T, Waxman I, Hyder S, Poneros J, Sharzehi K, Di Palma JA, Sejpal DV, Oh D, Hagen J, Rothstein R, Sawhney M, Berzin T, Malik Z, Chang K. Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. Dis Esophagus. 2019 Nov 13;32(9):doz029. doi: 10.1093/dote/doz029.
PubMed 31037293
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. 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 Registry
- ClinicalTrials.gov ID
- NCT02215291
- Acronym / sponsor ID
- 13_02
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- NinePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Aug 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.
Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.
Detailed description
This is a prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.
Up to 1000 patients from up to 20 sites nationwide.
There are no protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening examination may not require additional screening endoscopies. For patients with established disease, further surveillance endoscopies will vary based on the extent of the disease (e.g. every 3 months, every 6 months, annual), which is based on the following American Society for Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing EGD or esophagoscopy | – | –The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 20 sites; each site will have the opportunity to enroll up to 100 patients. There will be up to 1000 patients enrolled in the registry.
Key inclusion criteria (2 listed)
- Patients presenting for an endoscopic examination of the esophagus
- Ability to provide written, informed consent to participate in the Registry
Key exclusion criteria (1 listed)
- Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Percent of patients with histologically confirmed disease and a breakdown of diseases observed
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy
Time frame: Baseline
No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
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 29 Mar 2018.
- Derived from this study: PubMed 31037293Smith MS, Cash B, Konda V, Trindade AJ, Gordon S, DeMeester S, Joshi V, Diehl D, Ganguly E, Mashimo H, Singh S, Jobe B, McKinley M, Wallace M, Komatsu Y, Thakkar S, Schnoll-Sussman F, Sharaiha R, Kahaleh M, Tarnasky P, Wolfsen H, Hawes R, Lipham J, Khara H, Pleskow D, Navaneethan U, Kedia P, Hasan M, Sethi A, Samarasena J, Siddiqui UD, Gress F, Rodriguez R, Lee C, Gonda T, Waxman I, Hyder S, Poneros J, Sharzehi K, Di Palma JA, Sejpal DV, Oh D, Hagen J, Rothstein R, Sawhney M, Berzin T, Malik Z, Chang K. Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. Dis Esophagus. 2019 Nov 13;32(9):doz029. doi: 10.1093/dote/doz029.
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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.
Michael Smith, MD, MBA principal investigator
Temple University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagogastroduodenoscopy, run by NinePoint Medical at 18 sites 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 2 inclusion and 1 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215291, which also lists 1 linked publication.
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 29 Mar 2018; AzTrials last refreshed its copy on 27 Oct 2026.