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This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.
Imagio is a multi-modality device, comprised of one probe with the ability to image with diagnostic gray scale (B mode) ultrasound alone and gray scale in conjunction with OA together in a six up image.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagio OA/US (US and OA/US) | Experimental | Imagio OA/US (gray scale and opto-acoustic) |
|
| Imagio gray scale ultrasound | Experimental | Imagio gray scale ultrasound alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagio OA/US (US and OA/US) | Device | opto-acoustic plus gray scale ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) | 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) | Baseline to 12 months +/- 30 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radnet (Temecula) | Murrieta | California | 92562 | United States | ||
| Sally Jobe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Otto P, Kist K, Dornbluth NC, McCorvey BM, Zalev J, Herzog D, Clingman B, Miller T, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Oraevsky A. Clinical Feasibility Study of Combined Opto-Acoustic and Ultrasonic Imaging Modality Providing Co-registered Functional and Anatomical Maps of Breast Tumors. Presented at: 97th Scientific Assembly and Annual Meeting of The Radiological Society of North America; 2011 Nov 28; Chicago, IL. | ||
| Background | Otto P, Kist K, Dornbluth NC, Herzog D, Clingman B, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Oraevsky A. Clinical feasibility of Co-registered Opto-acoustic and Ultrasonic Imaging for Differentiation of Breast Tumors. Presented at: Annual Meeting: Society for Nuclear Medicine; 2011 Jun 6; San Antonio, TX. | ||
| Background | Zalev J (Ryerson Univ, Toronto, Canada), Kolios MC. Detecting Abnormal Vasculature from Photoacoustic Signals Using Wavelet-packet Features. Poster presented at: SPIE Photonics West Symposium; 2011 Jan 22-27; San Francisco, CA. | ||
| Background | Otto P, Kist K, Dornbluth NC, McCorvey BM, Zalev J, Herzog D, Clingman B, Miller T, Smith R, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Hernandez T, Oraevsky A. Feasibility of Co-registered Opto-Acoustic and Ulatrsonic Imaging for Differentiation of Malignant from Benign Breast Tumors. Presented at: American Institute of Ultrasound in Medicine Annual Convention; 2012 March 31; Phoenix, AZ. | ||
| Background | Zalev J, Herzog D, Clingman B, Miller T, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Tsyboulski D, Oraevsky A, Otto P, Kist K, Dornbluth NC, McCorvey BM. Clinical Feasibility Study of Combined Opto-Acoustic and Ultrasonic Imaging Modality Providing Coregistered Functional and Anatomical Maps of Breast Tumors. Presented at: Photons plus Ultrasound: Imaging and Sensing. SPIE/Bios, Photonics West Symposium; 2012 Jan 22; San Francisco, CA. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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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)
Prospective controlled multi-center pivotal study of Imagio Breast Imaging System; two imaging modalities (test and control) used on each subject/mass
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2015 | Apr 29, 2021 |
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| Imagio gray scale ultrasound | Device | gray scale ultrasound alone |
|
| Baseline to 12 months +/- 30 days follow-up |
| Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS) | 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) | Baseline to 12 months +/- 30 days follow-up |
| Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS) | 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) | Baseline to 12 months +/- 30 days follow-up |
| Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) | 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 | Baseline to 12 months +/- 30 days follow-up |
| Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) | 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 | Baseline to 12 months +/- 30 days follow-up |
| Englewood |
| Colorado |
| 80112 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Georgetown University Hospital, Department of Radiology | Washington D.C. | District of Columbia | 20007 | United States |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| Breast Care Atlanta | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Elizabeth Wende Breast Care | Rochester | New York | 14260 | United States |
| Solis Women's Health (North Carolina) | Greensboro | North Carolina | 27401 | United States |
| Cleveland Clinic, Breast Services DDI Clinical Research | Cleveland | Ohio | 44195 | United States |
| Weinstein Imaging Associates | Pittsburgh | Pennsylvania | 15220 | United States |
| Austin Radiological Association | Austin | Texas | 78731 | United States |
| MD Anderson Cancer Center, Department of Radiology and Breast Imaging | Houston | Texas | 77030 | United States |
| Solis Women's Health | Plano | Texas | 75075 | United States |
| Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center | San Antonio | Texas | 78229 | United States |
| Background | Otto P, Kist K, Dornbluth NC, McCorvey BM, Miller T, Herzog D, Clingman B, Zalev J, Ermilov S, Oraevsky A. Improve Differentiation of Breast Tumors Using Laser Opto-Acoustic Ultrasonic Imaging System. Poster presented at: European Congress of Radiology; 2012 Mar 1-5; Vienna, Austria. |
| Background | Otto P, Kist K, Dornbluth C, Stavros T, Ulissey M, Herzog D, Clingman B, Zalev J, Lavin P, Oraevsky A. Functional Images of Hemoglobin and Blood Oxygen Saturation Co-registered with Ultrasound Provide Accurate Differentiation of Breast Tumors. Presented at: American Institute of Ultrasound in Medicine Annual Convention; 2013 Apr 6-10; New York, NY. |
| Background | Stavros T, Lerner A, Burak W, Fine R, Boyd B, Miller T, Herzog D, Clingman B, Smith R, Zalev J, Ulissey M. Combining B-Mode Ultrasound and Opto-Acoustic Imaging to Evaluate Breast Lesions. Poster presented at: American Society of Breast Surgeons Annual Meeting; 2013 May 1-5; Chicago, IL. |
| Background | Otto P, Kist K, Dornbluth C, Stavros T, Ulissey M, Herzog D, Clingman B, Zalev J, Lavin P, Oraevsky A. Improved Differentiation of Breast Tumors using Novel Imaging System based on Co-Registered Opto-Acoustic Tomography and Ultrasound. Presented at European Congress of Radiology; 2013 Mar 7-11; Vienna, Austria. |
| Background | Stavros T, Lerner A, Burak W, Fine R, Boyd B, Miller T, Herzog D, Clingman B, Smith R, Zalev J, Ulissey M. Opto-Acoustic Breast Imaging, A New Technology. Poster presented at 23rd Annual National Interdisciplinary Breast Center Conference; 2013 Mar 23-27; Las Vegas, NV. |
| Background | Zalev J, Clingman B, Smith R, Herzog D, Miller T, Stavros AT, Ermilov S, Conjusteau A, Tsyboulski D, Oraevsky A, Kist K, Dornbluth C, Otto P. Real-time Opto-acoustic Imaging System for Clinical Assessment of Breast Lesions. Presented at: Photons plus Ultrasound: Imaging and Sensing, SPIE/BiOS, Photonics West Symposium; 3 Feb 2013; San Francisco, CA. |
| 37748954 | Derived | Ozcan BB, Xi Y, Dogan BE. Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis. Acad Radiol. 2024 Jan;31(1):121-130. doi: 10.1016/j.acra.2023.08.042. Epub 2023 Sep 23. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Diagnose (ITD)
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Masses | Masses evaluated by independent readers | Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects. | Number | masses |
| ||||||||||||||||
| Mass Diagnosis | Measure Description: Mass diagnosis by biopsy result or Truth Panel decision on benign status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) | 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) | Intent-to-diagnose population | Posted | Mean | 99% Confidence Interval | % benign+TPB masses correctly Id'd | Baseline to 12 months +/- 30 days follow-up |
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| |||||||||||||||||||||||||
| Secondary | Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) | 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) | Intent-to-Diagnose Population | Posted | Mean | 99% Confidence Interval | % of malignant masses I'd correctly | Baseline to 12 months +/- 30 days follow-up |
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| ||||||||||||||||||||||||||
| Secondary | Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS) | 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) | Intent-to-diagnose population | Posted | Mean | 99% Confidence Interval | % of benign+TPB masses I'd correctly | Baseline to 12 months +/- 30 days follow-up |
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| Secondary | Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS) | 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) | Intent-to-Diagnose Population | Posted | Mean | 99% Confidence Interval | Percentage (%) of malignant masses that | Baseline to 12 months +/- 30 days follow-up |
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| Secondary | Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) | 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 | Intent-to-Diagnose Population | Posted | Mean | 99% Confidence Interval | Percentage of reads | Baseline to 12 months +/- 30 days follow-up |
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| Secondary | Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) | 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 | Intent-to-Diagnose Population | Posted | Mean | 99% Confidence Interval | Percentage of reads | Baseline to 12 months +/- 30 days follow-up |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | 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. | 0 | 1,972 | 5 | 1,972 | 47 | 1,972 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device breakage | General disorders | MedDRA 16.0 | Systematic Assessment | (Right saline breast implant rupture) |
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| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | (Atrial fibrillation) |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | (Congestive heart failure) |
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| Non-small cell lung cancer Stage I | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | (Stage I, non-small cell lung cancer) |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | (hemothorax) |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | (pneumothorax) |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | (worsening of fibroids) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Procedural Dizziness | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Burns Second Degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Post Procedural Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Spinal Column Injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Paraesthesia | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Migraine | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Neuropathy Peripheral | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Thoracic Outlet Syndrome | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Postoperative Wound Infection | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Cystitis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Mastitis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Urinary Tract Infection | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Skin Warm | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Food Allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Gallbladder Disorder | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Breast Discharge | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaan Schaeffer, VP Clinical Operations | Seno Medical Instruments, Inc | 2106156501 | sschaeffer@senomedical.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Subjects (Cancer) |
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| Subjects (Other-TPC,HR) |
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| Subjects (Cancer) |
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| Subjects (Other-Truth Panel Cancer [TPC], high risk [HR]) |
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