CONFIDENCE Registry

Completed

• Conditions: Breast Abnormality Diagnosis
• Interventions: Device: Imagio OA/US

• Registration Number: NCT05084729
• Lead Sponsor: Seno Medical Instruments Inc.

Brief Summary

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.

Detailed Description

This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.

Study Timeline

• Study Start: 2020-09-11
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-20
• Status Verified: 2023-01
• Primary Completion: 2023-07-19
• Study Completion: 2023-07-19
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imagio OA/US	Imagio OA/US	Imagio optoacoustic

Primary Outcome Measures

Name	Time	Method
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	September 2024	This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Specificity, negative likelihood ratio, sensitivity and positive likelihood	September 2024	This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker	September 2024	i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer.; This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Quality of Life Assessment - Testing Morbidity Index	September 2024	This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations

Secondary Outcome Measures

Name	Time	Method
Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)	September 2024	This parameter will be reviewed for the Safety population
Characteristics of lymph node lesions/masses the device is used for	September 2024	This parameter will be reviewed for the Safety population
Incidence and nature of device and procedure related adverse events	September 2024	This parameter will be reviewed for the Safety population

Trial Locations

Locations (3)

Zorggroep Twente; 🇳🇱 Hengelo, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands