Clinical trial · Observational
CONFIDENCE Registry
A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
NCT05084729CI-TRIAL-00070294CONFIDENCEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Abnormality Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imagio OA/US | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Imagio OA/US
- description
- Imagio optoacoustic
- interventionNames
- Device: Imagio OA/US
Primary outcomes (4)
- measure
- Specificity, negative likelihood ratio, sensitivity and positive likelihood
- timeFrame
- September 2024
- description
- This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
- measure
- Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy
- timeFrame
- September 2024
- description
- This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - Subjects must meet all the following criteria to be included in the registry: 1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities, 2. Are females 18 years of age or older at the time of consent, 3. Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system. Exclusion Criteria - Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry: 1. Are pregnant. 2. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast. 3. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline. 4. Are currently undergoing phototherapy. 5. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus). 6. Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity. 7. Have previously participated in this registry, 8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
References
Publications (0)
Data not yet available
No reference posted for this study.