Abdominoplasty Clinical Trial
Official title:
Histologic Evaluation of Tissue Following Lutronic System Exposure
Enrollment of up to 25 subjects; subjects enrolled may be greater than subjects receiving test spot exposure visits. No pre-treatment medication prior to test spot exposure. Up to 6 tattoo points will be applied to each side of the abdomen immediately before or after test spot exposures to map and locate exposed spots on the excised pannis. Tattoos in the area to be resected will be placed to outline the test spot exposure areas. Photographs of exposed sites may be taken at investigator's discretion.
Enrolled subjects who qualify will be assigned to one of four groups depending on the time of
their screening appointment and scheduled abdominoplasty. Test spot exposures will take place
prior to abdominoplasty resections at the following possible time points (by group):
- Group A (up to n=5): Genius exposure 1-3 hours before tissue resection
- Group B (up to n=5): Genius exposure 30+7 days, 14+3 days, and 7+3 days before tissue
resection. All test spot exposure visits will have a follow-up visit at 7+3 days after
the test spot exposure visit.
- Group C (up to n=5): Genius exposure 90+14 days, 60+10 days, and 30+7 days before tissue
resection. All test spot exposure visits will have a follow-up visit at 7+3 days after
the test spot exposure visit.
- Group D (up to n=10): Genius, LaseMD, LaseMD FLEX, eCO2 and/or PicoPlus exposure 14+3
days, 7+3 days, and 1-3 hours before tissue resection. All test spot exposure visits
will have a follow-up visit at 7+3 days after the test spot exposure visit.
Subjects receive test spot exposures at sites on the abdomen that will be resected during
abdominoplasty. The area of the test spots will be approximately 2 x 2 cm2 but may be
appropriately adjusted for fit within the resected tissue area. Subject pain during exposure
will be monitored and recorded using a 0-10 Numeric Rating Scale.
Activities related to the abdominoplasty procedure are considered outside the scope of this
study and will not be recorded or reported on during this study. The subject will be exited
from the study prior to abdominoplasty procedures after all study related procedures with the
exception of tissue preparation of excised tissue are complete. Tissue preparation of excised
tissue will be completed after the subject has been exited from the study.
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