Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)

NCT03814824 | Completed Results FDA Device

• 1 other identifier: 18-0963
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Index procedure, up to 1 hour

Secondary Outcomes (1)

• Subjects With Dysplasia on Biopsies

  Index procedure

Study Arms (2)

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.

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.

Diagnostic Test: IRIS (Intelligent real-time image segmentation); Diagnostic Test: VLE (Volumetric laser endomicroscopy)

Interventions

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 with IRIS, followed by VLE without IRIS; VLE without IRIS, followed by VLE with IRIS

VLE (Volumetric laser endomicroscopy) DIAGNOSTIC_TEST

VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.

VLE with IRIS, followed by VLE without IRIS; VLE without IRIS, followed by VLE with IRIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• NinePoint Medical: collaborator
• Mayo Clinic: collaborator

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (27)

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• Levine 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.

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• Trindade AJ, Smith MS, Pleskow DK. The new kid on the block for advanced imaging in Barrett's esophagus: a review of volumetric laser endomicroscopy. Therap Adv Gastroenterol. 2016 May;9(3):408-16. doi: 10.1177/1756283X16639003. Epub 2016 Mar 21.

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• Wolfsen 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.

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• Trindade 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.

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• Swager 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.

  PMID: 28161451 BACKGROUND

• Swager 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.

  PMID: 27658906 BACKGROUND

• Leggett 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.

  PMID: 26344884 BACKGROUND

• Trindade 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.

  PMID: 26005011 BACKGROUND

• Trindade 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.

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• Leggett CL, Gorospe E, Owens VL, Anderson M, Lutzke L, Wang KK. Volumetric laser endomicroscopy detects subsquamous Barrett's adenocarcinoma. Am J Gastroenterol. 2014 Feb;109(2):298-9. doi: 10.1038/ajg.2013.422. No abstract available.

  PMID: 24496431 BACKGROUND

• Swager AF, Boerwinkel DF, de Bruin DM, Faber DJ, van Leeuwen TG, Weusten BL, Meijer SL, Bergman JJ, Curvers WL. Detection of buried Barrett's glands after radiofrequency ablation with volumetric laser endomicroscopy. Gastrointest Endosc. 2016 Jan;83(1):80-8. doi: 10.1016/j.gie.2015.05.028. Epub 2015 Jun 26.

  PMID: 26124075 BACKGROUND

• Trindade AJ, Sideridis K, Thomas RM. Buried Barrett's Esophagus Presenting as a Subepithelial Nodule. Am J Gastroenterol. 2016 Oct;111(10):1378. doi: 10.1038/ajg.2016.242. No abstract available.

  PMID: 27694877 BACKGROUND

• Mashimo H. Subsquamous intestinal metaplasia after ablation of Barrett's esophagus: frequency and importance. Curr Opin Gastroenterol. 2013 Jul;29(4):454-9. doi: 10.1097/MOG.0b013e3283622796.

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• Alshelleh M, Inamdar S, McKinley M, Stewart M, Novak JS, Greenberg RE, Sultan K, Devito B, Cheung M, Cerulli MA, Miller LS, Sejpal DV, Vegesna AK, Trindade AJ. Incremental yield of dysplasia detection in Barrett's esophagus using volumetric laser endomicroscopy with and without laser marking compared with a standardized random biopsy protocol. Gastrointest Endosc. 2018 Jul;88(1):35-42. doi: 10.1016/j.gie.2018.01.032. Epub 2018 Feb 2.

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• Trindade AJ, Inamdar S, Smith MS, Chang KJ, Leggett CL, Lightdale CJ, Pleskow DK, Sejpal DV, Tearney GJ, Thomas RM, Wallace MB. Volumetric laser endomicroscopy in Barrett's esophagus: interobserver agreement for interpretation of Barrett's esophagus and associated neoplasia among high-frequency users. Gastrointest Endosc. 2017 Jul;86(1):133-139. doi: 10.1016/j.gie.2016.11.026. Epub 2016 Nov 27.

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• Trindade AJ, Inamdar S, Smith MS, Rosen L, Han D, Chang KJ, Leggett CL, Lightdale CJ, Pleskow DK, Sejpal DV, Tearney GJ, Thomas RM, Wallace MB. Learning curve and competence for volumetric laser endomicroscopy in Barrett's esophagus using cumulative sum analysis. Endoscopy. 2018 May;50(5):471-478. doi: 10.1055/s-0043-121569. Epub 2017 Nov 27.

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• The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.

  PMID: 14652541 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Genes, BRCA1

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Genes, Tumor Suppressor; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Genes, Recessive

Limitations and Caveats

By utilizing expert users, we're unable to assess the impact of IRIS on novice interpretation. We also utilized a surveillance biopsy protocol that avoided areas of laser marking to avoid confounding and were thus unable to compare VLE-related dysplasia detection to that which would have occurred in the standardized biopsy protocol. Finally, although we did randomize the order of interpretation, it is not possible to eliminate all bias from a subjective interpretation paradigm.

Results Point of Contact

• Title: Dr. Arvind Trindade
• Organization: Northwell Health

atrindade@northwell.edu

516-387-3990

Study Officials

• Arvind Trindade, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 24, 2019
• Study Start: January 23, 2019
• Primary Completion: May 31, 2020
• Study Completion: February 28, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)