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Comparison · NCT05275556-bb990ced

CADe Device vs Colonoscopy (Standard of Care): Proximal Adenoma Detection Rate (pADR)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. CADe Device vs Colonoscopy (Standard of Care): Proximal Adenoma Detection Rate (pADR). Trial comparisons, record NCT05275556-bb990ced. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05275556-bb990ced

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3310.2970.366wilson
Risk in group 20.2850.2530.32wilson
Risk difference, group 1 minus group 20.0457-0.002580.0936newcombe hybrid score
Risk ratio, group 1 over group 21.160.9911.36log
Odds ratio, group 1 over group 21.240.9881.56log
Number needed to treat, for one more participant with the outcome on CADe Device than on Colonoscopy (Standard of Care)21.9from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: standard of care.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1CADe 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.
236713OG001
Group 2Colonoscopy (Standard of Care)The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.198694OG000

Outcome

Type
SECONDARY
Title
Proximal Adenoma Detection Rate (pADR)
Description
pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Time frame
Day 1
Population

Source ClinicalTrials.gov

Trial

Title
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
NCT number
NCT05275556
Phases
NA
Conditions
Colon Adenoma, Colon Polyp, Colon Lesion
Interventions
Computer-Assisted Detection (CADe) Device
Lead sponsor
Verily Life Sciences LLC
Results first posted
2025-01-14

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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