Device Trial Participant Snapshot: Lumicell Direct Visualization System (DVS)
Device Category: General & Plastic Surgery
Summary:
What is this device used for?
The Lumicell DVS is a medical tool used by a surgeon to help look at breast tissue after a piece of tumor has been removed during surgery. The device helps the doctor look at the remaining tissue to determine if all of the cancerous tissue was removed.
How is the device used?
Doctors use this device during a surgery to remove only the breast tumor and minimal healthy tissue around the tumor. The device is used with an imaging dye that helps highlight cancerous tissue still in the patient once most of the breast tumor has been removed.
What are the benefits of this device?
This device showed success in finding residual cancerous tissue within the body after the removal of tumor in the breast. This means a doctor would be able to see if there was undetected cancerous tissue left in the breast before ending the surgery.
What are the risks and potential harmful side effects of this device?
There were no device related harmful side effects reported; however, there were harmful side effects reported with the use of the imaging dye that is used with the device. The most common side effect reported was abnormal color of urine due to the dye in the drug. A rare, but serious side effect was anaphylaxis or hypersensitivity to the drug.
Demographics Snapshot:
Figure 1. Participant Demographics by Sex
Figure 2. Participant Demographics by Race
Figure 3. Participant Demographics by Ethnicity
Table 1: Participant Demographics
| Category | Average | Range |
|---|---|---|
| Age (years) | 62.3 | 36-83 |
| Body Mass Index (kg/m2) | 29.9 | 16.9-67.4 |
| Number of Participants | Percentage (%) | |
| Sex | ||
| Male | 0 | 0% |
| Female | 406 | 100% |
| Race | ||
| American Indian or Alaskan Native | 1 | 0.2% |
| Asian | 22 | 5.4% |
| Black or African American | 26 | 6.4% |
| Native Hawaiian or Pacific Islander | 1 | 0.2% |
| White | 337 | 83% |
| Other | 4 | 1.0% |
| Unknown or not reported | 15 | 3.7% |
| Ethnicity | ||
| Hispanic or Latino | 12 | 3% |
| Non-Hispanic or Latino | 383 | 94.0% |
| Unknown or not reported | 11 | 2.7% |
Who participated in the clinical trial studies?
The clinical study included adult, female patients with breast cancer. This study helped determine if the device was safe and effective. For more information about the demographics of all participants, please see Table 1.
What did the trials evaluate?
These trials were designed to determine how well the Lumicell DVS found remaining cancerous tissue. All patients received the imaging dye. The trial was designed to determine if doctors had better success with complete cancer removal after the imaging system was used versus before the imaging system was used in the same patient.
Were there any differences in how well the device worked or risks among different sexes, races, ethnicities, and age groups?
While we know the sex (all participants identified as female), age range, race, and ethnicity of the study patients, we do not have information on whether there were differences in benefits or risks across these groups.
Summary for Clinical Audiences
The trials were created to evaluate the proportion of patients who have residual cancer found in at least one device-guided shave among all patients in the treatment arm. In addition, acceptable sensitivity and specificity in detecting cancerous tissue were evaluated. This was accomplished through a randomized, controlled study format.