{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.7","upperLimit":"267.2","value":"54"},{"groupId":"OG001","lowerLimit":"10.5","upperLimit":"308.0","value":"66.8"}]}],"title":"Lumpectomy volume"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"71.2","value":"7.5"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"71.9","value":"7.7"}]}],"title":"SOC shave volume"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.1","upperLimit":"308.7","value":"66.4"},{"groupId":"OG001","lowerLimit":"21.9","upperLimit":"308","value":"76.7"}]}],"title":"SOC total volume"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"61.1","value":"0"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"0","value":"0"}]}],"title":"Therapeutic shave volume"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.2","upperLimit":"348.1","value":"77.5"},{"groupId":"OG001","lowerLimit":"21.9","upperLimit":"308.0","value":"76.7"}]}],"title":"Total volume"}],"denoms":[{"counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.","dispersionType":"95% Confidence Interval","groups":[{"description":"The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015.\n\nStudy Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.","id":"OG000","title":"Device Intervention: LUM Imaging System Used During Surgery"},{"description":"The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.","id":"OG001","title":"Standard of Care Arm"}],"paramType":"MEDIAN","populationDescription":"mITT and control populations","reportingStatus":"POSTED","timeFrame":"Day 1, during surgery","title":"Volume of Therapeutic Shaves Removed During Lumpectomy.","type":"SECONDARY","unitOfMeasure":"cm^3"}