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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864043
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
NinePoint Medical

Tracking Information
First Submitted Date  ICMJE August 2, 2016
First Posted Date  ICMJE August 11, 2016
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: August 10, 2016)
Performance of manually identified VLE features in predicting biopsy defined dysplasia [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Barrett's Esophagus
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 25, 2018)
150
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
100
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864043
Other Study ID Numbers  ICMJE 16-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NinePoint Medical
Study Sponsor  ICMJE NinePoint Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Wang, MD Mayo Clinic
PRS Account NinePoint Medical
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP