NCT03845907

Brief Summary

Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
4

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

November 7, 2018

Last Update Submit

April 2, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects with Treatment-related Events

    Safety of the Gen 1B duplex Optoacoustic (OA)/ Ultrasound (US) probe in breast applications as compared to Gen 1 with respect to treatment-related events

    At end of study, average of six months

  • Diagnostic Image Quality of Gen 1B

    Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison

    At end of study, average of six months

Secondary Outcomes (2)

  • Probe performance data comparison across skin types

    At end of study, average of six months

  • Image Quality between probes at reduced laser level

    At end of study, average of six months

Study Arms (2)

Imagio Gen 1B

ACTIVE COMPARATOR

Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe

Device: Gen 1BDevice: Gen 1

Imagio Gen 1

ACTIVE COMPARATOR

Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System

Device: Gen 1BDevice: Gen 1

Interventions

Gen 1BDEVICE

Diagnostic Ultrasound and Optoacoustic Imaging

Imagio Gen 1Imagio Gen 1B
Gen 1DEVICE

Diagnostic Ultrasound and Optoacoustic Imaging

Imagio Gen 1Imagio Gen 1B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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.
  • Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
  • Is willing and able to comply with protocol-required scans.

You may not qualify if:

  • Is pregnant or lactating.
  • Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, 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 sulfa, 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 a history of contact dermatitis induced by gold or chrome metal contact with skin.
  • Has an acute or chronic hematoma and/or acute ecchymosis of the breast.
  • Has had prior benign excisional breast biopsy within the past 18 months.
  • Has nipple rings that cannot be removed or are not removed during Imagio evaluation.
  • Currently has mastitis.
  • Has focal pain in the breast.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seno Medical

San Antonio, Texas, 78230, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • A. Thomas Stavros, MD

    Seno Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Unblinded feasibility study in healthy subjects
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

February 19, 2019

Study Start

December 19, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)