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SuspendedNCT03845907Updated Apr 6, 2020

Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

An interventional study of Gen 1B and Gen 1 in Breast Cancer, sponsored by Seno Medical Instruments Inc.. Suspended at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Seno Medical Instruments Inc. · Not applicable, Interventional, and Other

Why this study was suspended
Data on initial patients sufficient
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the detailed description

This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.

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Conditions studied

  • Breast Cancer
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In context

Lead sponsor

Seno Medical Instruments Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Active comparator
    Imagio Gen 1B

    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 1B · Device: Gen 1

  • Active comparator
    Imagio Gen 1

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

    Device: Gen 1B · Device: Gen 1

Interventions

  • DeviceGen 1B

    Diagnostic Ultrasound and Optoacoustic Imaging

  • DeviceGen 1

    Diagnostic Ultrasound and Optoacoustic Imaging

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What researchers measure

Primary outcomes

  1. 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

    Time frame: At end of study, average of six months

  2. 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

    Time frame: At end of study, average of six months

Secondary outcomes

  1. Probe performance data comparison across skin types

    The effect of skin pigmentation using the Fitzpatrick Scale (skin typing test), from Type I (always burns, never tans (palest; freckles) to Type VI never burns (deeply pigmented dark brown to darkest brown) will be used to determine similarities and differences between probes.

    Time frame: At end of study, average of six months

  2. Image Quality between probes at reduced laser level

    OA images with reduced laser level energy will be collected to determine via a 7 point image quality scale, where 1 is poor and 7 is best, which probe produces better images by independent readers

    Time frame: At end of study, average of six months

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Study locations

1 site
  • Seno Medical
    San Antonio, Texas 78230, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03845907
Lead sponsor
Seno Medical Instruments Inc.
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Dec 19, 2018
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Apr 6, 2020

Study contacts

A. Thomas Stavros, MD
study director · Seno Medical

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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