Colon AdenomaGAINNCT05275556
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
A study testing Computer-Assisted Detection (CADe) Device in people with Colon Adenoma and Colon Polyp, run by Verily Life Sciences LLC at 7 sites in 2 countries.
Trial summary
This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma, Colon Polyp, Colon Lesion
- What is being tested?
- Computer-Assisted Detection (CADe) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Mar 2022to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
- Between the ages of 45 and 80 years, inclusive
- Able and willing to provide written informed consent
Who cannot join
- Self-reported pregnancy
- Known diagnosis of Colorectal Cancer
- History of, or referral for, Inflammatory Bowel Disease
- Previous surgery involving the colon or rectum
- Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
- High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
- Referral for overt, symptomatic gastrointestinal bleeding
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011
Duke Health
Durham, North Carolina, 27710
ANRC Research
El Paso, Texas, 79912
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060
Mayo Clinic
Rochester, Minnesota, 55905
Israel2 sites
Elisha Medical Center
Haifa
Sourasky Medical Center (Ichilov)
Tel Aviv
About this study
This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.
- Conditions
- Colon Adenoma, Colon Polyp, Colon Lesion
- Being tested
- Computer-Assisted Detection (CADe) Device
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Detection (CADe) DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy (Standard of Care) | No intervention | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. |
| CADe Device | Experimental | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Receives: Device: Computer-Assisted Detection (CADe) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Adenomas Per Colonoscopy (APC)
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.
Measured: Day 1
Difference in Positive Percent Agreement (PPA)
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.
Measured: Day 1
Secondary outcomes (13)
Adenoma Detection Rate (ADR)
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.
Measured: Day 1
Number of False Alerts Per Procedure
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.
Measured: Day 1
Mean Withdrawal and Inspection Time (MWT)
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.
Measured: Day 1
Polyp Detection Rate (PDR)
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
Measured: Day 1
Proximal Adenoma Detection Rate (pADR)
pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Measured: Day 1
Flat Adenoma Detection Rate (fADR)
fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.
Measured: Day 1
Serrated Lesions Per Colonoscopy (SLPC)
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
Measured: Day 1
Serrated Lesions Detection Rate (SLDR)
SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.
Measured: Day 1
Adenoma Detection Rate Including Carcinoma (ADR*)
ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
Measured: Day 1
Small Adenoma Detection Rate (sADR)
sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.
Measured: Day 1
Polyps Per Colonoscopy (PPC)
PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.
Measured: Day 1
Advanced Adenoma Detection Rate (aADR)
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.
Measured: Day 1
False Positive Rate (FPR)
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Mar 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scooter Plowman, MD, Study director, Verily Life Sciences LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275556
- Sponsor's protocol ID
- 103820
- Acronym
- GAIN
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Leggett CL, Plowman RS, Surace L, Gorospe E, Lachter J, Ben-Ami Shor D, Friedenberg K, Leiman DA, Schlachter S, Patwardhan A, Goldenberg R, Rivlin E, Choi L, Coelho-Prabhu N, Kaltenbach T, Wallace M. Computer-aided polyp detection multicenter international randomized controlled study with a focus on community clinics: Geriatric Assessment-Driven Intervention clinical trial. Gastrointest Endosc. 2026 Aug;104(2):277-285.e3. doi: 10.1016/j.gie.2025.12.290. Epub 2026 Jan 16.
PubMed 41548723
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
- ClinicalTrials.gov ID
- NCT05275556
- Acronym / sponsor ID
- GAIN / 103820
- Conditions
- Colon Adenoma, Colon Polyp, Colon Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,410 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy (Standard of Care) | No intervention | –The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. |
| CADe Device | Experimental | Device: Computer-Assisted Detection (CADe) DeviceThe intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
- Between the ages of 45 and 80 years, inclusive
- Able and willing to provide written informed consent
Key exclusion criteria (7 listed)
- Self-reported pregnancy
- Known diagnosis of Colorectal Cancer
- History of, or referral for, Inflammatory Bowel Disease
- Previous surgery involving the colon or rectum
- Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted Detection (CADe) DeviceThe 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. | Device | CADe Device |
Primary outcome
Difference in Adenomas Per Colonoscopy (APC)
Time frame: Day 1
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.
Difference in Positive Percent Agreement (PPA)
Time frame: Day 1
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.
13 secondary outcomes
Adenoma Detection Rate (ADR)
Time frame: Day 1
Number of False Alerts Per Procedure
Time frame: Day 1
Mean Withdrawal and Inspection Time (MWT)
Time frame: Day 1
Polyp Detection Rate (PDR)
Time frame: Day 1
Proximal Adenoma Detection Rate (pADR)
Time frame: Day 1
Flat Adenoma Detection Rate (fADR)
Time frame: Day 1
Serrated Lesions Per Colonoscopy (SLPC)
Time frame: Day 1
Serrated Lesions Detection Rate (SLDR)
Time frame: Day 1
Adenoma Detection Rate Including Carcinoma (ADR*)
Time frame: Day 1
Small Adenoma Detection Rate (sADR)
Time frame: Day 1
Polyps Per Colonoscopy (PPC)
Time frame: Day 1
Advanced Adenoma Detection Rate (aADR)
Time frame: Day 1
False Positive Rate (FPR)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41548723Leggett CL, Plowman RS, Surace L, Gorospe E, Lachter J, Ben-Ami Shor D, Friedenberg K, Leiman DA, Schlachter S, Patwardhan A, Goldenberg R, Rivlin E, Choi L, Coelho-Prabhu N, Kaltenbach T, Wallace M. Computer-aided polyp detection multicenter international randomized controlled study with a focus on community clinics: Geriatric Assessment-Driven Intervention clinical trial. Gastrointest Endosc. 2026 Aug;104(2):277-285.e3. doi: 10.1016/j.gie.2025.12.290. Epub 2026 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scooter Plowman, MD study director
Verily Life Sciences LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Detection (CADe) Device in people with Colon Adenoma and Colon Polyp, run by Verily Life Sciences LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Adenomas Per Colonoscopy (APC) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.