GI Genius helped endoscopists find more adenomas in a randomized trial

In the randomized Italian trial that FDA reviewed, colonoscopy with GI Genius found adenomas in 55.1% of low-risk patients, against 42.0% with standard colonoscopy.

22
Benefit status
Reported
Evidence
Found by a court or regulator
Observed
Sources
2 publications
Download data CiteSuggest a correction

Benefits

Benefit

An adenoma detection rate of 55.1% with GI Genius against 42.0% with standard colonoscopy

Awaiting review

Outcome identifiers

Unresolved

Not reviewedUnresolved

Category

Improved Task Accuracy

Awaiting review

Status

Reported benefit

Awaiting review

Beneficiary groups

People. Organizations.

Awaiting review

Beneficiaries

Unresolved

Not reviewedUnresolved

Reach

Unresolved

Not reviewedUnresolved

Distribution and access

Unresolved

Not reviewedUnresolved

Duration

Unresolved

Not reviewedUnresolved

Expected?

Yes

Awaiting review

Costs and harms

Unresolved

Not reviewedUnresolved

AI system

System

GI Genius

Awaiting review

Model

This is an explicit unresolved assignment: the sources on record do not settle this question.

Not reviewedUnresolved

Release

Unresolved

Not reviewedUnresolved

Provider

Unresolved

Not reviewedUnresolved

Role

Unresolved

Not reviewedUnresolved

Configuration

Unresolved

Not reviewedUnresolved

Inputs and outputs

Unresolved

Not reviewedUnresolved

Autonomy

Unresolved

Not reviewedUnresolved

Workflow

Endoscopists with an adenoma detection rate of 25 to 40% used the program during white-light colonoscopy. A minimum withdrawal time of six minutes was required. Histology confirmed each lesion.

Awaiting review

Human oversight

Unresolved

Not reviewedUnresolved

Relation to AI

Patients were randomized to colonoscopy with or without GI Genius, performed by the same endoscopists, so the trial isolates the contribution of the program.

Awaiting review

AI contribution

Patients were randomized to colonoscopy with or without GI Genius, performed by the same endoscopists, so the trial isolates the contribution of the program.

Awaiting review

Measurement

Studies

Randomized. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Study design

Randomized. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measurement

Randomized 1:1 multicenter trial with histology as reference; FDA reanalysis in low-risk patients. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Setting and sample

700 patients at three Italian hospitals; 263 low-risk patients in the FDA analysis; six endoscopists. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measures

Adenoma detection rate and adenomas per colonoscopy. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Comparison

Standard colonoscopy without the program. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Results

ADR 55.1% against 42.0%; APC 0.81 against 0.57. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Additional value from AI

Adjusted ADR difference of 13.1 percentage points. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Limitations

Limited patient diversity; six endoscopists in Italy; cancer outcomes not measured. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Denominators

One colonoscopy per patient. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Materials for replication

ClinicalTrials.gov NCT04079478. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Money

Kind of value

The kind of monetary value is unclear.

Not reviewedUnresolved

Amount

The monetary value is not established.

Not reviewedUnresolved

Currency and prices

The currency and price basis are unclear.

Not reviewedUnresolved

Period and unit

The period and unit of the monetary estimate are unclear.

Not reviewedUnresolved

Realization

Whether the monetary value was realized is unclear.

Not reviewedUnresolved

Recipients and payers

The recipients and payers are unclear.

Not reviewedUnresolved

Gross or net

Whether the monetary figure includes costs is unclear.

Not reviewedUnresolved

Included costs

The costs included in the estimate are unclear.

Not reviewedUnresolved

Comparison

The financial comparison is not established.

Not reviewedUnresolved

Method

The method used to calculate monetary value is unclear.

Not reviewedUnresolved

Return and payback

The return on investment or payback period is not established.

Not reviewedUnresolved

People and places

Participants

Developer: Cosmo Artificial Intelligence - AI, Ltd. Operator: Humanitas Research Hospital, Nuovo Regina Margherita Hospital and Valduce Hospital (AID trial).

Awaiting review

Jurisdictions

Benefit: Milan, Rome and Como, Italy. Developer: Ireland. Operator: Italy.

Awaiting review

Ownership and control

Unresolved

Not reviewedUnresolved

Dependencies

Unresolved

Not reviewedUnresolved

Cross-border connections

Unresolved

Not reviewedUnresolved

Geopolitical implications

The geopolitical implications are unclear.

Not reviewedUnresolved

Follow-up

Conditions for replication

The program runs with standard white-light endoscopy. Endoscopists use the marks as an aid and keep inspecting the whole colon.

Awaiting review

Replication attempts

Unresolved

Not reviewedUnresolved

Later findings

Unresolved

Not reviewedUnresolved

Availability

Unresolved

Not reviewedUnresolved

Institutional decision

A relevant institutional decision has not been established.

Not reviewedUnresolved

Grounds

The grounds for an institutional decision are unclear.

Not reviewedUnresolved

Action and result

The result of an institutional decision is not established.

Not reviewedUnresolved

Success criterion

The criterion for a successful institutional decision is unclear.

Not reviewedUnresolved

Evidence

Source numbers

AIBD-0623-source-0001–0002

Awaiting review

Citations

Numbered references below.

Awaiting review

Language

Unresolved

Not reviewedUnresolved

Source relationships

Independent, Relationship unreported

Awaiting review

Original evidence

Unresolved

Not reviewedUnresolved

Access and versions

Unresolved

Not reviewedUnresolved

Supported findings

Unresolved

Not reviewedUnresolved

Evidence strength

Found by a regulator. Sources: one independent regulatory document and one peer-reviewed study with authorship relationship unassessed. The cited evidence includes no independent study or report. [1] [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [1] [2]

Missing evidence

Unresolved

Not reviewedUnresolved

Grades

Assessed benefits

People. Organizations.

Awaiting review

Depth

People: 2. Organizations: 2.

Awaiting review

Reasons

People: Patients in the GI Genius arm had at least one adenoma found in 55.1% of procedures against 42.0% in the standard arm. Organizations: Endoscopists found 0.81 adenomas per colonoscopy with the program against 0.57 without it.

Awaiting review

Observed or intended

Unresolved

Not reviewedUnresolved

Rubric

Unresolved

Not reviewedUnresolved

Assessor and date

Unresolved

Not reviewedUnresolved

Alternative assessments

Unresolved

Not reviewedUnresolved

Fill

Found by a regulator

Awaiting review

Entry details

Kind

The case describes an evaluation or a study. A regulatory review of a randomized controlled trial. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Field

Healthcare.

Awaiting review

Purpose

GI Genius was built to help endoscopists detect colonic lesions such as polyps and adenomas in real time. Higher adenoma detection is that purpose.

Awaiting review

Dates

Observed: November 2019. Updated: 29 October 2026.

Awaiting review

Stage

The system was used in a pilot. A randomized trial in three hospitals before US authorization. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Version

SHA-256: 4595da4a3cdc…

Awaiting review

SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.

References

Other identifiers

Unresolved

Not reviewedUnresolved

Category mappings

Unresolved

Not reviewedUnresolved

Citable summary

Unresolved

Not reviewedUnresolved

Revisions

1 revision. Latest: 29 October 2026.

Awaiting review

Sources

  1. Peer-reviewed study Authorship unassessed

    Repici A, Badalamenti M, Maselli R, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology 2020;159(2):512-520.e7.

  2. Regulatory document Independent author

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for GI Genius (DEN200055): decision summary. Granted 2021-04-09.

Collections: Scrutiny and findings, Cross-border cases.

Cite this case

BibTeX Download BibTeX

Version 4595da4a3cdc, archived in the edition of 29 October 2026

Benefit marks

Depth

The number and color show the depth of a benefit.

  1. A convenience, or time or money saved.
  2. A measurable improvement in a result or ability.
  3. A lasting change, an ability restored, or a risk removed.
  4. A serious harm averted or a serious condition resolved in time.
  5. A life or livelihood preserved, or a change documented across a population.

Beneficiary

  • Circle: a person
  • Square: an organization
  • Triangle: society

Evidence

  • Solid. A court or regulator found a benefit, or researchers independently studied it.

  • Hatched. Independent reporting.

  • Outline. Claimed by the parties. Only the people or organizations involved, or sources whose independence has not been assessed, support the benefit.

The fill changes with the evidence. The depth color stays the same.

How benefits are assessed