NL-OMON46537
Withdrawn
Not Applicable
A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging with Opto-acoustics to Diagnose BrEast CaNCEr - CONFIDENCE-01
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seno Medical Instruments, Inc.
- Enrollment
- 150
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
- •2\. Are males or females 18 years of age or older at the time of consent,
- •3\. Either have a BI\-RADS 1 mammogram (50 subjects) or have been referred for a breast ultrasound because of a breast mass/finding found (2100 subjects) on at least one of the following examinations:
- •a. Physical palpation or other signs symptoms (i.e. nipple discharge, skin changes, inflammation, etc.),
- •b. Screening or diagnostic mammography (including 2D mammography or tomosynthesis, CESM),
- •c. Supplemental screening ultrasound exam and/or CDU,
- •d. Screening or diagnostic breast MRI,
- •e. Screening or diagnostic molecular breast imaging (MBI technetium 99m sestamibi scans of the breast),
- •f. Screening or diagnostic PET/CT or PEM,
- •4\. Be willing and able to complete all procedures and assessments in accordance with the
Exclusion Criteria
- •1\. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass),
- •2\. Mass(es) not visible under screening or diagnostic ultrasound (includes Imagio IUS)
- •3\. Are pregnant,
- •4\. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast within one probe length or 4 cm of each mass to be included,
- •5\. Are experiencing photo\-toxicity or photo\-sensitivity or are undergoing treatment for a photosensitive condition such as porphyria or lupus erythematosus,
- •6\. Have received or are receiving chemotherapy for any type of cancer up to 90 days prior to the date of the baseline Imagio procedure,
- •7\. Have previously participated in this registry,
- •8\. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
An observational registry study on the use of ENCRUSO RAL- Everolimus eluting stent in indian populatioCTRI/2022/03/040921ano Therapeutics Private Limited
Recruiting
Phase 4
A Observational Study to Evaluate Sirolimus Eluting Coronary Stent for the Treatment of the narrowing of the coronary artery, resulting in a poor blood flow to your heart muscle.CTRI/2012/04/002612Multimedics400
Recruiting
Not Applicable
Evaluation of the Impact of Fractional flow reserve and Optical Coherence Tomography on the Outcomes of Percutaneous coronary intervention in Diabetic PatientsCTRI/2021/09/036375Ananthapuri Hospitals and Research Institute
Recruiting
Not Applicable
A follow up study to evaluate the safety and effectiveness of tissue valve (aortic) among Indian patientsHealth Condition 1: I358- Other nonrheumatic aortic valve disordersCTRI/2022/08/044557SRM Institutes for Medical Science SIMS
Not yet recruiting
Not Applicable
Study of Management of Large Bone Defects.CTRI/2024/05/066962AO Innovation Translation Center (AO ITC)