Barrett's Esophagus Without DysplasiaNCT03814824
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)
A study testing IRIS (Intelligent real-time image segmentation) and VLE (Volumetric laser endomicroscopy) in people with Barrett's Esophagus Without Dysplasia and Barrett's Esophagus With Dysplasia, run by Northwell Health at 3 sites in United States.
Trial summary
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus Without Dysplasia, Barrett's Esophagus With Dysplasia, Barrett's Esophagus With Low Grade Dysplasia
- What is being tested?
- IRIS (Intelligent real-time image segmentation) and VLE (Volumetric laser endomicroscopy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jan 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older at the time of informed consent
- Barrett's esophagus greater than 2 cm in length
- Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care
Who cannot join
- Less than 18 years old at the time of informed consent
- Unable to provide written informed consent
- Esophageal stenosis/stricture preventing VLE
- Esophagitis
- Severe medical comorbidities preventing endoscopy
- Pregnancy
- Uncontrolled coagulopathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
North Shore University Hospital
Manhasset, New York, 11030
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Read the detailed description
Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients regardless of the study participation in this study would receive VLE with and without IRIS clinically. They will be randomized into VLE without IRIS first vs VLE with IRIS first. The BUDDY Randomization System, provided for use by the Northwell Health Biostatistics Unit, will be used for this. Randomization will be stratified based on prior diagnosis of dysplasia. The order in which the patient is randomized to will be recorded on the case report form. There will be concealed allocation as the study coordinator performing the randomization will not know the order of the next allocation.
Both VLE and IRIS imaging are being performed as standard of care. However, randomization of the order allows for comparison of the two. Regions of interest (ROI) will be recorded using a full scan and recorded on the case report form. The time to identification of ROIs will also be recorded. Each group will then cross over such that the VLE without IRIS group will then have IRIS turned on. ROI will then be recorded for each group based on full scans. A consensus ROI will be recorded based on the two exams. Only one ROI per centimeter will be allowed to avoid overlapping of laser marks. In addition, VLE without IRIS and IRIS marks within 75 frames of each other or 2 hours (on a clock face orientation) will be considered the same target.
Laser marking will then be performed. A double laser mark will be applied to all IRIS ROIs. A single laser mark will be applied to VLE ROIs. Targeted biopsies will be taken of all laser marks and placed in separate biopsy jars. Biopsies will be taken in between the laser marks for double laser marked areas. For single laser marks, biopsies will be taken on either side of the laser mark. Resection of visible lesions will then occur per standard of care (if present) followed by random biopsies of the segment. Random biopsies are pinch biopsies every 1 cm the length of the Barrett's in a 4 quadrant fashion per gastrointestinal society guidelines. There are no additional research biopsies being performed outside this study. The targeted biopsies are based on the VLE features that are suspicious for dysplasia and thus standard of care. The other biopsies being performed here are random biopsies which are also being performed for standard of care. Biopsied samples will be stored per standard of care procedures per the pathology department. They will not be stored for future research purposes.
Following each procedure, the physician will be asked a series of Likert Scale questions to assess the utility of IRIS in that procedure, including how it impacts their confidence in image interpretation, their ability to assimilate data more easily and quickly, and their overall perception of the technology.
Although, the VLE with IRIS and VLE without IRIS are being performed as standard of care, all adverse events will be recorded and reported to the IRB.
All data will be entered into a central encrypted REDCap database.
Expert pathologists who specialize in gastrointestinal pathology will read the histology. A second gastrointestinal pathologist will confirm any histologic diagnosis of dysplasia. This is the standard of care at Northwell Health and academic medical centers per gastrointestinal society guidelines.
All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS enhanced VLE) will be performed as standard of care. The prospective data collection and initial randomization will be the research component. All data collected will be de-identified before being transferred into a database. This will be kept in a safe place that is only accessible to the research team.
- Conditions
- Barrett's Esophagus Without Dysplasia, Barrett's Esophagus With Dysplasia, Barrett's Esophagus With Low Grade Dysplasia, Barrett's Esophagus With High Grade Dysplasia, Barrett's Esophagus With Dysplasia, Unspecified
- Being tested
- IRIS (Intelligent real-time image segmentation), VLE (Volumetric laser endomicroscopy)
- Keywords
- VLE, Volumetric laser endomicroscopy, IRIS, Intelligent real-time image segmentation, Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRIS (Intelligent real-time image segmentation)Diagnostic test
IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy)Diagnostic test
VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| VLE without IRIS, followed by VLE with IRIS | Active comparator | VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging. Receives: Diagnostic Test: IRIS (Intelligent real-time image segmentation); Diagnostic Test: VLE (Volumetric laser endomicroscopy) |
| VLE with IRIS, followed by VLE without IRIS | Active comparator | VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone. Receives: Diagnostic Test: IRIS (Intelligent real-time image segmentation); Diagnostic Test: VLE (Volumetric laser endomicroscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Image Interpretation (Mean)
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Measured: Index procedure, up to 1 hour
Time for Image Interpretation (Mean - Scaled)
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Measured: Index procedure, up to 1 hour
Time for Image Interpretation (Median - Scaled)
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Measured: Index procedure, up to 1 hour
Secondary outcomes (1)
Subjects With Dysplasia on Biopsies
Biopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).
Measured: Index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start23 Jan 2019
- Primary completion31 May 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Barrett's Esophagus Without DysplasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- NinePoint Medical, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Arvind Trindade, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814824
- Sponsor's protocol ID
- 18-0963
- Status last verified
- Sep 2022
- First submitted
- 8 Jan 2019
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3.
PubMed 26526079Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
PubMed 25162890Pohl H, Welch HG. The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence. J Natl Cancer Inst. 2005 Jan 19;97(2):142-6. doi: 10.1093/jnci/dji024.
PubMed 15657344Bhat SK, McManus DT, Coleman HG, Johnston BT, Cardwell CR, McMenamin U, Bannon F, Hicks B, Kennedy G, Gavin AT, Murray LJ. Oesophageal adenocarcinoma and prior diagnosis of Barrett's oesophagus: a population-based study. Gut. 2015 Jan;64(1):20-5. doi: 10.1136/gutjnl-2013-305506. Epub 2014 Apr 3.
PubMed 24700439Corley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact of endoscopic surveillance on mortality from Barrett's esophagus-associated esophageal adenocarcinomas. Gastroenterology. 2013 Aug;145(2):312-9.e1. doi: 10.1053/j.gastro.2013.05.004. Epub 2013 May 11.
PubMed 23673354Levine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus. Gastroenterology. 1993 Jul;105(1):40-50. doi: 10.1016/0016-5085(93)90008-z.
PubMed 8514061Jankowski M, Wani S. Diagnostic and Management Implications of Basic Science Advances in Barrett's Esophagus. Curr Treat Options Gastroenterol. 2015 Mar;13(1):16-29. doi: 10.1007/s11938-014-0040-9.
PubMed 25567106Trindade AJ, Smith MS, Pleskow DK. The new kid on the block for advanced imaging in Barrett's esophagus: a review of volumetric laser endomicroscopy. Ther Adv Gastroenterol. 2016 May;9(3):408-16. doi: 10.1177/1756283X16639003. Epub 2016 Mar 21.
PubMed 27134668Wolfsen HC, Sharma P, Wallace MB, Leggett C, Tearney G, Wang KK. Safety and feasibility of volumetric laser endomicroscopy in patients with Barrett's esophagus (with videos). Gastrointest Endosc. 2015 Oct;82(4):631-40. doi: 10.1016/j.gie.2015.03.1968. Epub 2015 May 6.
PubMed 25956472Trindade AJ, Leggett CL, Chang KJ. Volumetric laser endomicroscopy in the management of Barrett's esophagus. Curr Opin Gastroenterol. 2017 Jul;33(4):254-260. doi: 10.1097/MOG.0000000000000366.
PubMed 28402993Swager AF, de Groof AJ, Meijer SL, Weusten BL, Curvers WL, Bergman JJ. Feasibility of laser marking in Barrett's esophagus with volumetric laser endomicroscopy: first-in-man pilot study. Gastrointest Endosc. 2017 Sep;86(3):464-472. doi: 10.1016/j.gie.2017.01.030. Epub 2017 Feb 2.
PubMed 28161451Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.
PubMed 27658906Leggett CL, Gorospe EC, Chan DK, Muppa P, Owens V, Smyrk TC, Anderson M, Lutzke LS, Tearney G, Wang KK. Comparative diagnostic performance of volumetric laser endomicroscopy and confocal laser endomicroscopy in the detection of dysplasia associated with Barrett's esophagus. Gastrointest Endosc. 2016 May;83(5):880-888.e2. doi: 10.1016/j.gie.2015.08.050. Epub 2015 Sep 3.
PubMed 26344884Trindade AJ, Vamadevan AS, Sejpal DV. Finding a needle in a haystack: use of volumetric laser endomicroscopy in targeting focal dysplasia in long-segment Barrett's esophagus. Gastrointest Endosc. 2015 Oct;82(4):756; discussion 757. doi: 10.1016/j.gie.2015.03.1984. Epub 2015 May 21. No abstract available.
PubMed 26005011Trindade AJ, George BJ, Berkowitz J, Sejpal DV, McKinley MJ. Volumetric laser endomicroscopy can target neoplasia not detected by conventional endoscopic measures in long segment Barrett's esophagus. Endosc Int Open. 2016 Mar;4(3):E318-22. doi: 10.1055/s-0042-101409.
PubMed 27004250
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03814824
- Acronym / sponsor ID
- 18-0963
- Conditions
- Barrett's Esophagus Without Dysplasia, Barrett's Esophagus With Dysplasia, Barrett's Esophagus With Low Grade Dysplasia, Barrett's Esophagus With High Grade Dysplasia, Barrett's Esophagus With Dysplasia, Unspecified
- Keywords
- VLE, Volumetric laser endomicroscopy, IRIS, Intelligent real-time image segmentation, Barrett's Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- NinePoint Medical, Mayo Clinic
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 7 Oct 2022
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 prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Detailed description
Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients regardless of the study participation in this study would receive VLE with and without IRIS clinically. They will be randomized into VLE without IRIS first vs VLE with IRIS first. The BUDDY Randomization System, provided for use by the Northwell Health Biostatistics Unit, will be used for this. Randomization will be stratified based on prior diagnosis of dysplasia. The order in which the patient is randomized to will be recorded on the case report form. There will be concealed allocation as the study coordinator performing the randomization will not know the order of the next allocation.
Both VLE and IRIS imaging are being performed as standard of care. However, randomization of the order allows for comparison of the two. Regions of interest (ROI) will be recorded using a full scan and recorded on the case report form. The time to identification of ROIs will also be recorded. Each group will then cross over such that the VLE without IRIS group will then have IRIS turned on. ROI will then be recorded for each group based on full scans. A consensus ROI will be recorded based on the two exams. Only one ROI per centimeter will be allowed to avoid overlapping of laser marks. In addition, VLE without IRIS and IRIS marks within 75 frames of each other or 2 hours (on a clock face orientation) will be considered the same target.
Laser marking will then be performed. A double laser mark will be applied to all IRIS ROIs. A single laser mark will be applied to VLE ROIs. Targeted biopsies will be taken of all laser marks and placed in separate biopsy jars. Biopsies will be taken in between the laser marks for double laser marked areas. For single laser marks, biopsies will be taken on either side of the laser mark. Resection of visible lesions will then occur per standard of care (if present) followed by random biopsies of the segment. Random biopsies are pinch biopsies every 1 cm the length of the Barrett's in a 4 quadrant fashion per gastrointestinal society guidelines. There are no additional research biopsies being performed outside this study. The targeted biopsies are based on the VLE features that are suspicious for dysplasia and thus standard of care. The other biopsies being performed here are random biopsies which are also being performed for standard of care. Biopsied samples will be stored per standard of care procedures per the pathology department. They will not be stored for future research purposes.
Following each procedure, the physician will be asked a series of Likert Scale questions to assess the utility of IRIS in that procedure, including how it impacts their confidence in image interpretation, their ability to assimilate data more easily and quickly, and their overall perception of the technology.
Although, the VLE with IRIS and VLE without IRIS are being performed as standard of care, all adverse events will be recorded and reported to the IRB.
All data will be entered into a central encrypted REDCap database.
Expert pathologists who specialize in gastrointestinal pathology will read the histology. A second gastrointestinal pathologist will confirm any histologic diagnosis of dysplasia. This is the standard of care at Northwell Health and academic medical centers per gastrointestinal society guidelines.
All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS enhanced VLE) will be performed as standard of care. The prospective data collection and initial randomization will be the research component. All data collected will be de-identified before being transferred into a database. This will be kept in a safe place that is only accessible to the research team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLE without IRIS, followed by VLE with IRIS | Active comparator | Diagnostic Test: IRIS (Intelligent real-time image segmentation), Diagnostic Test: VLE (Volumetric laser endomicroscopy)VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging. |
| VLE with IRIS, followed by VLE without IRIS | Active comparator | Diagnostic Test: IRIS (Intelligent real-time image segmentation), Diagnostic Test: VLE (Volumetric laser endomicroscopy)VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older at the time of informed consent
- Barrett's esophagus greater than 2 cm in length
- Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care
Key exclusion criteria (7 listed)
- Less than 18 years old at the time of informed consent
- Unable to provide written informed consent
- Esophageal stenosis/stricture preventing VLE
- Esophagitis
- Severe medical comorbidities preventing endoscopy
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 |
|---|---|---|
| IRIS (Intelligent real-time image segmentation)IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes. | Diagnostic test | VLE with IRIS, followed by VLE without IRIS, VLE without IRIS, followed by VLE with IRIS |
| VLE (Volumetric laser endomicroscopy)VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus. | Diagnostic test | VLE with IRIS, followed by VLE without IRIS, VLE without IRIS, followed by VLE with IRIS |
Primary outcome
Time for Image Interpretation (Mean)
Time frame: Index procedure, up to 1 hour
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Time for Image Interpretation (Mean - Scaled)
Time frame: Index procedure, up to 1 hour
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Time for Image Interpretation (Median - Scaled)
Time frame: Index procedure, up to 1 hour
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
1 secondary outcome
Subjects With Dysplasia on Biopsies
Time frame: Index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26526079Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3.
- Background: PubMed 25162890Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
- Background: PubMed 15657344Pohl H, Welch HG. The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence. J Natl Cancer Inst. 2005 Jan 19;97(2):142-6. doi: 10.1093/jnci/dji024.
- Background: PubMed 24700439Bhat SK, McManus DT, Coleman HG, Johnston BT, Cardwell CR, McMenamin U, Bannon F, Hicks B, Kennedy G, Gavin AT, Murray LJ. Oesophageal adenocarcinoma and prior diagnosis of Barrett's oesophagus: a population-based study. Gut. 2015 Jan;64(1):20-5. doi: 10.1136/gutjnl-2013-305506. Epub 2014 Apr 3.
- Background: PubMed 23673354Corley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact of endoscopic surveillance on mortality from Barrett's esophagus-associated esophageal adenocarcinomas. Gastroenterology. 2013 Aug;145(2):312-9.e1. doi: 10.1053/j.gastro.2013.05.004. Epub 2013 May 11.
- Background: PubMed 8514061Levine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus. Gastroenterology. 1993 Jul;105(1):40-50. doi: 10.1016/0016-5085(93)90008-z.
- Background: PubMed 25567106Jankowski M, Wani S. Diagnostic and Management Implications of Basic Science Advances in Barrett's Esophagus. Curr Treat Options Gastroenterol. 2015 Mar;13(1):16-29. doi: 10.1007/s11938-014-0040-9.
- Background: PubMed 27134668Trindade AJ, Smith MS, Pleskow DK. The new kid on the block for advanced imaging in Barrett's esophagus: a review of volumetric laser endomicroscopy. Ther Adv Gastroenterol. 2016 May;9(3):408-16. doi: 10.1177/1756283X16639003. Epub 2016 Mar 21.
- Background: PubMed 25956472Wolfsen HC, Sharma P, Wallace MB, Leggett C, Tearney G, Wang KK. Safety and feasibility of volumetric laser endomicroscopy in patients with Barrett's esophagus (with videos). Gastrointest Endosc. 2015 Oct;82(4):631-40. doi: 10.1016/j.gie.2015.03.1968. Epub 2015 May 6.
- Background: PubMed 28402993Trindade AJ, Leggett CL, Chang KJ. Volumetric laser endomicroscopy in the management of Barrett's esophagus. Curr Opin Gastroenterol. 2017 Jul;33(4):254-260. doi: 10.1097/MOG.0000000000000366.
- Background: PubMed 28161451Swager AF, de Groof AJ, Meijer SL, Weusten BL, Curvers WL, Bergman JJ. Feasibility of laser marking in Barrett's esophagus with volumetric laser endomicroscopy: first-in-man pilot study. Gastrointest Endosc. 2017 Sep;86(3):464-472. doi: 10.1016/j.gie.2017.01.030. Epub 2017 Feb 2.
- Background: PubMed 27658906Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.
- Individual participant dataSharing planned: No
Related trials for Barrett's Esophagus Without Dysplasia
RecruitingObservational study
Lucid Registry Study
Barrett Esophagus, Esophageal Adenocarcinoma
Active, not recruiting
Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
Barrett Esophagus, Esophageal Adenocarcinoma
Not yet recruitingPhase 1
Development of Fluorescent Lectin Tracers With Dedicated Technology for in Vivo Detection of Esophageal Dysplasia in Barrett Patients
Barrett's Esophagus With or Without Dysplasia, Barrett Esophagus Adenocarcinoma
Recruiting
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Barrett Esophagus, Barretts Esophagus With Dysplasia
RecruitingPhase 2
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
Barrett's Esophagus Without Dysplasia, Barrett Oesophagitis With Dysplasia
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.
Arvind Trindade, MD principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRIS (Intelligent real-time image segmentation) and VLE (Volumetric laser endomicroscopy) in people with Barrett's Esophagus Without Dysplasia and Barrett's Esophagus With Dysplasia, run by Northwell Health at 3 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 3 inclusion and 7 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time for Image Interpretation (Mean) (time frame: Index procedure, up to 1 hour). The study lists 3 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 NCT03814824, which also lists 27 linked publications.
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 7 Oct 2022.