Trial Outcomes & Findings for Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS) (NCT NCT03814824)
NCT ID: NCT03814824
Last Updated: 2022-10-07
Results Overview
The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
Index procedure, up to 1 hour
Results posted on
2022-10-07
Participant Flow
133 of 148 subjects were randomized during their EGD procedure. Of those not randomized, 8 subjects had a segment of Barrett's esophagus less than 2cm, 3 subjects had esophagitis (LA Grade B or higher), and 4 subjects did not have a complete VLE exam due to technical malfunctions with the device.
Participant milestones
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
|
Overall Study
COMPLETED
|
67
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
n=67 Participants
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
n=66 Participants
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=67 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=133 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=67 Participants
|
28 Participants
n=66 Participants
|
60 Participants
n=133 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=67 Participants
|
38 Participants
n=66 Participants
|
73 Participants
n=133 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=67 Participants
|
18 Participants
n=66 Participants
|
42 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=67 Participants
|
48 Participants
n=66 Participants
|
91 Participants
n=133 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Index procedure, up to 1 hourThe length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Outcome measures
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
n=67 Participants
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
n=66 Participants
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
Seattle Protocol
Standardized method of biopsy collection entailing taking biopsies every 1cm of the Barrett's segment in a 4 quadrant fashion, the current standard of care.
|
|---|---|---|---|
|
Time for Image Interpretation (Mean)
Total interpretation time (VLE/IRIS)
|
4.0 Minutes
Standard Deviation 3.75
|
4.6 Minutes
Standard Deviation 3.43
|
—
|
|
Time for Image Interpretation (Mean)
Interpretation time (VLE alone)
|
3.8 Minutes
Standard Deviation 2.08
|
2.4 Minutes
Standard Deviation 2.10
|
—
|
|
Time for Image Interpretation (Mean)
First Interpretation Time
|
3.8 Minutes
Standard Deviation 2.08
|
4.6 Minutes
Standard Deviation 3.43
|
—
|
|
Time for Image Interpretation (Mean)
Second Interpretation Time
|
4.0 Minutes
Standard Deviation 3.75
|
2.4 Minutes
Standard Deviation 1.5
|
—
|
PRIMARY outcome
Timeframe: Index procedure, up to 1 hourThe length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Outcome measures
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
n=67 Participants
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
n=66 Participants
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
Seattle Protocol
Standardized method of biopsy collection entailing taking biopsies every 1cm of the Barrett's segment in a 4 quadrant fashion, the current standard of care.
|
|---|---|---|---|
|
Time for Image Interpretation (Mean - Scaled)
Scaled First Interpretation Time
|
1.2 Centimeters/Minutes
Standard Deviation 0.86
|
1.1 Centimeters/Minutes
Standard Deviation 0.62
|
—
|
|
Time for Image Interpretation (Mean - Scaled)
Scaled Second Interpretation Time
|
1.3 Centimeters/Minutes
Standard Deviation 1.25
|
0.6 Centimeters/Minutes
Standard Deviation 0.47
|
—
|
PRIMARY outcome
Timeframe: Index procedure, up to 1 hourThe length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
Outcome measures
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
n=67 Participants
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
n=66 Participants
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
Seattle Protocol
Standardized method of biopsy collection entailing taking biopsies every 1cm of the Barrett's segment in a 4 quadrant fashion, the current standard of care.
|
|---|---|---|---|
|
Time for Image Interpretation (Median - Scaled)
Scaled First Interpretation Time
|
1.0 Centimeters/Minutes
Standard Deviation 0.86
|
1.0 Centimeters/Minutes
Standard Deviation 0.62
|
—
|
|
Time for Image Interpretation (Median - Scaled)
Scaled Second Interpretation Time
|
1.0 Centimeters/Minutes
Standard Deviation 1.25
|
0.5 Centimeters/Minutes
Standard Deviation 0.47
|
—
|
SECONDARY outcome
Timeframe: Index procedureBiopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).
Outcome measures
| Measure |
VLE Without IRIS, Followed by VLE With IRIS
n=133 Participants
VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
VLE With IRIS, Followed by VLE Without IRIS
n=133 Participants
VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
|
Seattle Protocol
n=100 Participants
Standardized method of biopsy collection entailing taking biopsies every 1cm of the Barrett's segment in a 4 quadrant fashion, the current standard of care.
|
|---|---|---|---|
|
Subjects With Dysplasia on Biopsies
|
29 Participants with dysplasia on biopsies
|
34 Participants with dysplasia on biopsies
|
24 Participants with dysplasia on biopsies
|
Adverse Events
VLE Without IRIS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VLE With IRIS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place