Status:
TERMINATED
Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis
Lead Sponsor:
Helix Medical Systems
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-70 years
Phase:
NA
Brief Summary
In the United States, breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second most common cause of death from cancer in women (after lung cancer). App...
Eligibility Criteria
Inclusion
- Female age between 21-70 years.
- Subject has mammography or ultrasound findings
- Subject is scheduled for biopsy.
- Subject is scheduled for ultrasound breast scan.
- Subject understands the study procedure.
- Subject is willing to sign the inform consent and comply with the study requirements.
Exclusion
- Age \< 21 years or \> 70 years.
- Subject undergo previous breast surgery
- Known blood coagulation disorders.
- Known cardiac disorders.
- Breast infection / breast abscess / breast pains.
- Ipsilateral breast scar in same quadrant as current lesion
- Recent breast trauma.
- Pregnant or lactating woman
- Subject has bleeding disorder.
- Subject is suffering extreme general weakness.
- Subject objects to the study protocol.
- Physician objection.
- Known cognitive or psychiatric disorder
- Participation in any other clinical trial
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00355745
Start Date
July 1 2006
End Date
July 1 2009
Last Update
June 9 2011
Active Locations (1)
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1
RAMBAM Medical Center
Haifa, Israel