Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT04030104
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optoacoustic Images Versus Imagio® Ultrasound
Sponsor:
Seno Medical Instruments Inc.
Organization:
Study Overview
Official Title:
Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reader-02
Brief Summary:
The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.
Detailed Description:
This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study.
Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.
Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: