Trial Outcomes & Findings for The PIONEER-01 Study of the Imagio Breast Imaging System (NCT NCT01943916)
NCT ID: NCT01943916
Last Updated: 2023-02-08
Results Overview
Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2105 participants
Primary outcome timeframe
Baseline to 12 months +/- 30 days follow-up
Results posted on
2023-02-08
Participant Flow
Prospective controlled multi-center pivotal study of Imagio Breast Imaging System; two imaging modalities (test and control) used on each subject/mass
Sixteen (16) centers performing Imagio ultrasound alone (IUS) and Imagio optoacoustic/ultrasound imaging (OA/US) to image breast masses, without using OA/US results for diagnosis; study compared results of each imaging modality (IUS vs. OA/US) to detect malignancy (based on biopsy diagnosis or truth panel decision as ground truth)
Participant milestones
| Measure |
Overall Population
Each subject served as her own control, with imaging of each mass by both the test Imagio (IUS+OA) and control (IUS only) modalities; therefore baseline data are not broken into each arm - test and control due the numbers being the same for each arm.
|
|---|---|
|
Overall Study
STARTED
|
2105
|
|
Overall Study
COMPLETED
|
1739
|
|
Overall Study
NOT COMPLETED
|
366
|
Reasons for withdrawal
| Measure |
Overall Population
Each subject served as her own control, with imaging of each mass by both the test Imagio (IUS+OA) and control (IUS only) modalities; therefore baseline data are not broken into each arm - test and control due the numbers being the same for each arm.
|
|---|---|
|
Overall Study
Technically invalid images
|
10
|
|
Overall Study
Enrollment Failure
|
23
|
|
Overall Study
Pilot Phase exclusion
|
100
|
|
Overall Study
Quality Assurance Reader Fail
|
130
|
|
Overall Study
Technical Failure
|
39
|
|
Overall Study
Protocol Deviation No Biopsy
|
25
|
|
Overall Study
No Truth Panel Review
|
38
|
|
Overall Study
Protocol Deviation
|
1
|
Baseline Characteristics
Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.
Baseline characteristics by cohort
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore baseline data are for overall population only.
|
|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 14.7 • n=1739 Participants
|
|
Sex: Female, Male
Female
|
1739 Participants
n=1739 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1739 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
255 Participants
n=1739 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1471 Participants
n=1739 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
Asian
|
57 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
Black or African American
|
216 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
White
|
1372 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
More than one race
|
81 Participants
n=1739 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=1739 Participants
|
|
Region of Enrollment
United States
|
1739 Participants
n=1739 Participants
|
|
Number of Masses
Subjects (Benign + TPB)
|
1038 masses
n=1038 Participants • Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.
|
|
Number of Masses
Subjects (Cancer)
|
652 masses
n=652 Participants • Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.
|
|
Number of Masses
Subjects (Other-TPC,HR)
|
49 masses
n=49 Participants • Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.
|
|
Mass Diagnosis
Subjects (Benign+Truth Panel Benign [TPB])
|
1038 Participants
n=1739 Participants
|
|
Mass Diagnosis
Subjects (Cancer)
|
652 Participants
n=1739 Participants
|
|
Mass Diagnosis
Subjects (Other-Truth Panel Cancer [TPC], high risk [HR])
|
49 Participants
n=1739 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-diagnose population
Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)
|
14.9 % benign+TPB masses correctly Id'd
Interval 12.9 to 16.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-Diagnose Population
Sensitivity difference for Imagio OA/US Imagio relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)
|
-2.7 % of malignant masses I'd correctly
Interval -3.7 to -1.6
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-diagnose population
Specificity for each imaging modality, Imagio OA/US (Imagio) and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
n=1739 Participants
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS)
|
28.1 % of benign+TPB masses I'd correctly
Interval 25.8 to 30.5
|
43.0 % of benign+TPB masses I'd correctly
Interval 40.4 to 45.7
|
SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-Diagnose Population
Sensitivity for each imaging modality, Imagio OA/US and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
n=1739 Participants
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS)
|
98.6 Percentage (%) of malignant masses that
Interval 97.8 to 99.1
|
96.0 Percentage (%) of malignant masses that
Interval 94.5 to 97.0
|
SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-Diagnose Population
Percentage of reads where breast mass was downgraded from one BI-RADS (BR) category to a lower BR category on the basis of additional information from the Imagio OA/US imaging modality compared to IUS, includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)
|
34.5 Percentage of reads
Interval 33.1 to 35.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-Diagnose Population
Percentage of reads where breast mass was upgraded from one BI-RADS (BR) category to a higher BR category on the basis of additional information from the Imagio optoacoustic plus grayscale (OA/US) imaging modality compared to Imagio grayscale (IUS), includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5
Outcome measures
| Measure |
Overall Population
n=1739 Participants
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
|
OA/US
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
|
|---|---|---|
|
Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)
|
0.7 Percentage of reads
Interval 0.4 to 1.0
|
—
|
Adverse Events
Safety Population
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=1972 participants at risk
Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore safety data are for overall safety population only.
|
|---|---|
|
General disorders
Device breakage
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Cardiac disorders
Atrial fibrillation
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer Stage I
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
Other adverse events
| Measure |
Safety Population
n=1972 participants at risk
Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore safety data are for overall safety population only.
|
|---|---|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.25%
5/1972 • Number of events 5 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Post Procedural Contusion
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Paraesthesia
|
0.51%
10/1972 • Number of events 10 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Dizziness
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Migraine
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Neuropathy Peripheral
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Thoracic Outlet Syndrome
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Postoperative Wound Infection
|
0.05%
1/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Cystitis
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Mastitis
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Injury, poisoning and procedural complications
Urinary Tract Infection
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.10%
2/1972 • Number of events 2 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Skin and subcutaneous tissue disorders
Skin Warm
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Renal and urinary disorders
Pollakiuria
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Renal and urinary disorders
Renal Failure
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Cardiac disorders
Palpitations
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Cardiac disorders
Tachycardia
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Immune system disorders
Food Allergy
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Blood and lymphatic system disorders
Anemia
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Endocrine disorders
Hypothyroidism
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Gastrointestinal disorders
Constipation
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
General disorders
Influenza Like Illness
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Reproductive system and breast disorders
Breast Discharge
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
|
Vascular disorders
Hypertension
|
0.05%
1/1972 • Number of events 1 • Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
|
Additional Information
Shaan Schaeffer, VP Clinical Operations
Seno Medical Instruments, Inc
Phone: 2106156501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study are the property of Seno Medical Instruments, Inc. All publications (manuscripts, abstracts or other modes of presentation) must be submitted and reviewed and approved in writing by Seno Medical Instruments, Inc., in advance of submission. The over all study results will first be submitted as a primary paper.
- Publication restrictions are in place
Restriction type: OTHER