At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
Single Endoscopy Proceduredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
In Brief
A clinical study evaluating Single Endoscopy Procedure for Endoscopy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndoscopy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartAug 2016
Primary CompletionSep 2016
Study CompletionOct 2016
TodayJul 2026
First PostedApr 28, 2016
Enrollment StartAug 18, 2016
Primary CompletionSep 23, 2016
Study CompletionOct 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.2 years ago
Interventions
Single Endoscopy Proceduredevice
All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.