Trial · NCT05275556
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
NCT05275556, Not applicable, Completed, Verily Life Sciences LLC; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study). Trials, record NCT05275556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05275556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
- NCT number
- NCT05275556
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,410 participants, actual
- Lead sponsor
- Verily Life Sciences LLC
- Conditions
- Colon Adenoma, Colon Polyp, Colon Lesion
- Interventions
- Computer-Assisted Detection (CADe) Device
- First posted
- 2022-03-11
- Last updated
- 2025-01-14
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Adenomas Per Colonoscopy (APC) | 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. |
| Primary | Difference in Positive Percent Agreement (PPA) | 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. |
| Secondary | Adenoma Detection Rate (ADR) | Day 1 | 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. |
| Secondary | Number of False Alerts Per Procedure | Day 1 | 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. |
| Secondary | Mean Withdrawal and Inspection Time (MWT) | Day 1 | 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. |
| Secondary | Polyp Detection Rate (PDR) | Day 1 | Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected. |
| Secondary | Proximal Adenoma Detection Rate (pADR) | Day 1 | pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon. |
| Secondary | Flat Adenoma Detection Rate (fADR) | Day 1 | fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected. |
| Secondary | Serrated Lesions Per Colonoscopy (SLPC) | Day 1 | SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies. |
| Secondary | Serrated Lesions Detection Rate (SLDR) | Day 1 | SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Adenomas Per Colonoscopy (APC) | Day 1 | Intent-to-Treat | Resected adenomas | LEAST_SQUARES_MEAN |
| PRIMARY | Difference in Positive Percent Agreement (PPA) | Day 1 | Intent-to-Treat | Proportion of significant lesions | LEAST_SQUARES_MEAN |
| SECONDARY | Adenoma Detection Rate (ADR) | Day 1 | Intent-to-Treat | Percentage of participants with adenomas | NUMBER |
| SECONDARY | Number of False Alerts Per Procedure | Day 1 | Intent-to-Treat | Number of false alerts | NUMBER |
| SECONDARY | Mean Withdrawal and Inspection Time (MWT) | Day 1 | Convenience sample of available videos | minutes | MEAN |
| SECONDARY | Polyp Detection Rate (PDR) | Day 1 | Intent-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proximal Adenoma Detection Rate (pADR) | Day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Flat Adenoma Detection Rate (fADR) | Day 1 | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serrated Lesions Per Colonoscopy (SLPC) | Day 1 | Intent-to-Treat | serated lesions per colonoscopy | LEAST_SQUARES_MEAN |
| SECONDARY | Serrated Lesions Detection Rate (SLDR) | Day 1 | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Adenomas Per Colonoscopy (APC) | Colonoscopy (Standard of Care) | 0.60 | 95% Confidence Interval 0.56 to 0.64 | Resected adenomas | |
| Difference in Adenomas Per Colonoscopy (APC) | CADe Device | 0.74 | 95% Confidence Interval 0.71 to 0.77 | Resected adenomas | |
| Difference in Positive Percent Agreement (PPA) | Colonoscopy (Standard of Care) | 0.62 | 95% Confidence Interval 0.58 to 0.66 | Proportion of significant lesions | |
| Difference in Positive Percent Agreement (PPA) | CADe Device | 0.56 | 95% Confidence Interval 0.52 to 0.60 | Proportion of significant lesions | |
| Adenoma Detection Rate (ADR) | Colonoscopy (Standard of Care) | 38.9 | 95% Confidence Interval 35.3 to 42.6 | Percentage of participants with adenomas | |
| Adenoma Detection Rate (ADR) | CADe Device | 42.9 | 95% Confidence Interval 39.2 to 46.6 | Percentage of participants with adenomas | |
| Number of False Alerts Per Procedure | CADe Device | 417 | Number of false alerts | ||
| Mean Withdrawal and Inspection Time (MWT) | Colonoscopy (Standard of Care) | 8.97 | Standard Deviation 4.97 | minutes | |
| Mean Withdrawal and Inspection Time (MWT) | CADe Device | 9.34 | Standard Deviation 4.08 | minutes | |
| Polyp Detection Rate (PDR) | Colonoscopy (Standard of Care) | 364 | Participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colonoscopy (Standard of Care) | 694 | |
| Overall Study | STARTED | CADe Device | 716 | |
| Overall Study | COMPLETED | Colonoscopy (Standard of Care) | 694 | |
| Overall Study | COMPLETED | CADe Device | 713 | |
| Overall Study | NOT COMPLETED | Colonoscopy (Standard of Care) | 0 | |
| Overall Study | NOT COMPLETED | CADe Device | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colonoscopy (Standard of Care) | 0 | 694 |
| Total, all-cause mortality | CADe Device | 0 | 713 |
| Total, other adverse events | Colonoscopy (Standard of Care) | 0 | 694 |
| Total, other adverse events | CADe Device | 0 | 713 |
| Total, serious adverse events | Colonoscopy (Standard of Care) | 0 | 694 |
| Total, serious adverse events | CADe Device | 0 | 713 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41548723 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CADe Device vs Colonoscopy (Standard of Care): Serrated Lesions Detection Rate (SLDR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Adenoma Detection Rate Including Carcinoma (ADR*) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Advanced Adenoma Detection Rate (aADR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Polyp Detection Rate (PDR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Flat Adenoma Detection Rate (fADR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Proximal Adenoma Detection Rate (pADR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): Small Adenoma Detection Rate (sADR) | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): deaths from any cause | Trial comparisons |
| CADe Device vs Colonoscopy (Standard of Care): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05275556
GET https://conductscience.org/api/trials/v1/NCT05275556/results?page=2