An interventional study of Imagio OA/US in Feasibility Study for Thyroid Indication, sponsored by Seno Medical Instruments Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Seno Medical Instruments Inc. · Not applicable, Interventional, and Diagnostic
Thyroid Feasibility Study
This is an early R\&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules
200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.
This study's enrollment of 37 is below the median of 81 across 118 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →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.
Exclusion Criteria:
Imagio opto-acoustic gray-scale ultrasound scan
Device: Imagio OA/US
Diagnostic opto-acoustic gray-scale ultrasound
Also known as: opto-acoustic gray-scale ultrasound
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.
Time frame: 12-24 months
Trial was terminated early due to corporate strategy changes
| Milestone | Imagio OA/US Scan |
|---|---|
| Started | 37 |
| Completed | 36 |
| Not completed | 1 |
| Withdrew: Screen fail | 1 |
The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.
No measurements were reported for this outcome.
Collected over AEs were collected during Imagio scanning at baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imagio OA/US Scan | 1/36 (2.8%) | 0/36 (0%) | 1/36 (2.8%) |
| Event | Imagio OA/US Scan |
|---|---|
| PainGeneral disorders | 1/36 |
36 patients under-going an Imagio exam, 1 screen failure prior to Imagio exam
| Age, Continuous(Years) | Imagio OA/US Scan |
|---|---|
| Median | 57 ± 15 |
| Sex: Female, Male(Participants) | Imagio OA/US Scan |
|---|---|
| Female | 26 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Imagio OA/US Scan |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 32 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Imagio OA/US Scan |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 36 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Imagio OA/US Scan |
|---|---|
| United States | 37 |
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This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Seno Medical Instruments Inc.