Claire OCT System helped surgeons remove cancer left at the margins

In a trial that FDA reviewed, surgeons using the Claire OCT System after standard care cleared residual cancer in 7 of 35 patients, a 20.0% relative reduction.

  • 3 a person

    Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation.

  • 2 an organization

    Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

The same patients' margins after standard care alone. Measured.

Without the system
17.0% with at least one unaddressed positive margin
With it
13.6% after use of the device
The system’s part
Each patient in the device arm was assessed first with standard care alone and then with the device, so the seven conversions are attributed to decisions aided by the device.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
Claire OCT System with the ImgAssist AI detection algorithm
Made by
Perimeter Medical Imaging AI, Inc.
Used by
Breast surgeons at the investigational sites of the randomized trial (NCT05113927)
Where
Investigational sites, United States
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System. Approved 2026-03-03.

    Seven (7) out of 35 patients in the study with one or more positive margin after a SOC lumpectomy procedure were converted to fully negative margins after device-aided adjunctive decisions.

Details

AI system

Reported configuration

ImgAssist 2.0

Workflow

Surgeons trained to read OCT images completed a supervised roll-in phase before the randomized phase. The device was used after standard intraoperative margin assessment was complete. The algorithm was locked before the final part of the trial.

Follow-up

Conditions for replication

The patient has biopsy-confirmed breast cancer and undergoes lumpectomy. Surgeons use the images alongside standard methods and keep post-operative pathology.

Entry details

Sector

Healthcare.

Purpose

Perimeter Medical Imaging AI built the Claire OCT System to help surgeons evaluate the margins of tissue removed during lumpectomy for breast cancer.

References

Other identifiers

Clinicaltrials_gov: NCT05113927.

Not yet checked: model, provider, role, configuration, inputs and outputs, autonomy, human oversight, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, category mappings.

Cite this record

Peter H. Vartanian. (2026). Claire OCT System helped surgeons remove cancer left at the margins (AIBD-0788). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0788.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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