Probe-based Volumetric Laser Endomicroscopy (pVLE) of End... | NCT02366039

Studies
Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia

NCT02366039

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Barrett's Esophagus With High Grade Dsyplasia
Early Esophageal Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Aug 10, 2023Actual

Completion Date

Aug 10, 2023Actual

First Submitted Date

Feb 11, 2015

First Submission Date that Met QC Criteria

Feb 18, 2015

First Posted Date

Feb 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Name	Class
Fred Hutchinson Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology

Detailed Description

To assess the ability of pVLE to visualize subsurface architecture of EMR tissue, as compared to histology in both in vivo and ex vivo imaging.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Label	Type	Description	Intervention Names
EMR		patients undergoing clinically indicated endoscopic mucosal resection as standard of care will be asked to participate for this observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia	We will assess descriptive and diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive values) of the Nvision pVLE device in visualizing dysplasia as compared to standard histopathology	at time of endoscopic mucosal resection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females over the age of 18 years.
Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
Ability to provide written, informed consent.
Females must be willing to take a pregnancy test if still capable of bearing a child.

Exclusion Criteria:

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/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
Patients with known eosinophilic esophagitis.
Patients who 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 Willebrand's disease or other known platelet malfunction disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

subjects undergoing clinically-indicated EMR for BE dysplasia will be invited to participate

Sampling Method

Non-Probability Sample

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms