Trial Outcomes & Findings for Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (NCT NCT05275556)
NCT ID: NCT05275556
Last Updated: 2025-01-14
Results Overview
Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1410 participants
Primary outcome timeframe
Day 1
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Colonoscopy (Standard of Care)
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Overall Study
STARTED
|
694
|
716
|
|
Overall Study
COMPLETED
|
694
|
713
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Baseline characteristics by cohort
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
Total
n=1407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.42 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
60.66 years
STANDARD_DEVIATION 9.16 • n=7 Participants
|
60.54 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
369 Participants
n=5 Participants
|
383 Participants
n=7 Participants
|
752 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
652 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
1318 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
551 participants
n=5 Participants
|
561 participants
n=7 Participants
|
1112 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
143 participants
n=5 Participants
|
152 participants
n=7 Participants
|
295 participants
n=5 Participants
|
|
Colonoscopy Indication
Screening
|
373 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
750 Participants
n=5 Participants
|
|
Colonoscopy Indication
Surveillance
|
277 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
|
Colonoscopy Indication
Diagnostic (symptomatic)
|
44 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Intent-to-Treat
Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Difference in Adenomas Per Colonoscopy (APC)
|
0.60 Resected adenomas
Interval 0.56 to 0.64
|
0.74 Resected adenomas
Interval 0.71 to 0.77
|
PRIMARY outcome
Timeframe: Day 1Population: Intent-to-Treat
Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Difference in Positive Percent Agreement (PPA)
|
0.62 Proportion of significant lesions
Interval 0.58 to 0.66
|
0.56 Proportion of significant lesions
Interval 0.52 to 0.6
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Adenoma Detection Rate (ADR)
|
38.9 Percentage of participants with adenomas
Interval 35.3 to 42.6
|
42.9 Percentage of participants with adenomas
Interval 39.2 to 46.6
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=713 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Number of False Alerts Per Procedure
|
417 Number of false alerts
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Convenience sample of available videos
The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=660 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=669 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Mean Withdrawal and Inspection Time (MWT)
|
8.97 minutes
Standard Deviation 4.97
|
9.34 minutes
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-treat
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Polyp Detection Rate (PDR)
|
364 Participants
|
425 Participants
|
SECONDARY outcome
Timeframe: Day 1pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Proximal Adenoma Detection Rate (pADR)
|
198 Participants
|
236 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Flat Adenoma Detection Rate (fADR)
|
19 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Serrated Lesions Per Colonoscopy (SLPC)
|
0.34 serated lesions per colonoscopy
Interval 0.3 to 0.38
|
0.46 serated lesions per colonoscopy
Interval 0.42 to 0.5
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Serrated Lesions Detection Rate (SLDR)
|
156 Participants
|
219 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
ADR\* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Adenoma Detection Rate Including Carcinoma (ADR*)
|
271 Participants
|
307 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Small Adenoma Detection Rate (sADR)
|
201 Participants
|
236 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Polyps Per Colonoscopy (PPC)
|
1.03 Polyps per colonoscopy
Interval 0.95 to 1.11
|
1.32 Polyps per colonoscopy
Interval 1.24 to 1.41
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-treat
aADR is defined as the percentage of patients with at least one adenoma ≥ 10 mm, or any adenoma \< 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous.
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=694 Participants
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=713 Participants
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
Advanced Adenoma Detection Rate (aADR)
|
60 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat
FPR is defined as the proportion of colorectal lesions resected and biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates).
Outcome measures
| Measure |
Colonoscopy (Standard of Care)
n=715 Resected lesions
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
|
CADe Device
n=939 Resected lesions
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.
|
|---|---|---|
|
False Positive Rate (FPR)
|
0.22 proportion of resected lesions
Interval 0.19 to 0.26
|
0.31 proportion of resected lesions
Interval 0.28 to 0.35
|
Adverse Events
Colonoscopy (Standard of Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CADe Device
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 PIs may publish, but there are limitations to protect confidential information and/or allow the sponsor to publish first.
- Publication restrictions are in place
Restriction type: OTHER