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EGD with NvisionVLE with Real Time Targeting for Barrett's Esophagus (DDP Trial)

N/A
Waitlist Available
Led By Kenneth Wang, MD
Research Sponsored by NinePoint Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post data collection
Awards & highlights

DDP Trial 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).

Eligible Conditions
  • Barrett's Esophagus

DDP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post data collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post data collection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Performance of manually identified VLE features in predicting biopsy defined dysplasia
Secondary outcome measures
Per Biopsy Sensitivity and specificity for detecting dysplasia
Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia
Per Patient Sensitivity and specificity for detecting dysplasia

DDP Trial Design

1Treatment groups
Experimental Treatment
Group I: EGD with NvisionVLE with Real Time TargetingExperimental Treatment2 Interventions
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

Find a Location

Who is running the clinical trial?

NinePoint MedicalLead Sponsor
7 Previous Clinical Trials
1,358 Total Patients Enrolled
Kenneth Wang, MDPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
631 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
2016. "Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02864043.
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