Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System (DDP)

• ClinicalTrials.gov Identifier: NCT02864043
• Recruitment Status: Active, not recruiting
• First Posted: August 11, 2016
• Last Update Posted: March 4, 2020
• Sponsor: NinePoint Medical
• Information provided by (Responsible Party): NinePoint Medical

Tracking Information

• First Submitted Date: August 2, 2016
• First Posted Date: August 11, 2016
• Last Update Posted Date: March 4, 2020
• Actual Study Start Date: September 2016
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2019)

Performance of manually identified VLE features in predicting biopsy defined dysplasia [ Time Frame: Up to 2 years post data collection ]

To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia

• Original Primary Outcome Measures (submitted: August 10, 2016): Performance of manually identified VLE features in predicting biopsy defined dysplasia [ Time Frame: 6 months ]

Current Secondary Outcome Measures (submitted: September 4, 2019)

• Per Patient Sensitivity and specificity for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
  1. To determine the absolute per-patient sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.
• Per Biopsy Sensitivity and specificity for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
  2. To determine the absolute per-biopsy sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.
• Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia [ Time Frame: Up to 2 years post data collection ]
  3. To compare, on a per-biopsy basis, the performance of VLE and standard-of-care to standard-of-care alone in detecting dysplasia.

• Original Secondary Outcome Measures (submitted: August 10, 2016): Sensitivity and specificity of VLE criteria for detecting dysplasia [ Time Frame: 6 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
• Official Title: Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
• Brief Summary: The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

Detailed Description

The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.

This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).

Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Barrett's Esophagus

Intervention

• Device: NvisionVLE with Real Time Targeting
  Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe
• Procedure: esophagogastroduodenoscopy (EGD)
  Standard of care EGD

Study Arms

EGD with NvisionVLE with Real Time Targeting

Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy

Interventions:

• Device: NvisionVLE with Real Time Targeting
• Procedure: esophagogastroduodenoscopy (EGD)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 25, 2018): 150
• Original Estimated Enrollment (submitted: August 10, 2016): 100
• Estimated Study Completion Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients over the age of 18.
• Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
• Ability to provide written, informed consent.
• No significant esophagitis (LA grade < B, C and D).

Exclusion Criteria:

• Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
• Patients without visible BE at time of study EGD.
• Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
• Prior esophageal or gastric surgical resection.
• Significant esophageal stricture requiring dilatation.
• Patients who require anticoagulation for whom biopsy would be contraindicated.
• Patients who are known to be pregnant.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02864043
• Other Study ID Numbers: 16-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: NinePoint Medical
• Study Sponsor: NinePoint Medical
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kenneth Wang, MD; Mayo Clinic

• PRS Account: NinePoint Medical
• Verification Date: March 2020