Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

NCT05022602 | Completed Results FDA Device

• 1 other identifier: Gen 2 - 01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).

Conditions

Breast Cancer Stage

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Imagio Image Sets Collected

  Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.

  Baseline

• Number of Subjects With Completed Pathology Results

  Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied

  Baseline

Study Arms (1)

Imagio

EXPERIMENTAL

Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes

Device: Imagio

Interventions

Imagio DEVICE

Imagio - both ultrasound probe and Duplex OA probe

Imagio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a signed and dated informed consent, prior to initiation of any study-related activities.
• Is at least 18 years of age.
• Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
• Is willing and able to comply with protocol-required scans

You may not qualify if:

• Is pregnant or lactating.
• Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
• Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
• Is currently undergoing phototherapy.
• Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
• Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
• Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
• Currently has mastitis.
• Prisoners

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead
• American College of Radiology: collaborator

Study Sites (1)

UT Health

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Shaan Schaeffer
• Organization: Seno Medical, Inc.

sschaeffer@senomedical.com

6106983259

Study Officials

• Pam Otto, MD

  UTHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: August 19, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)