NCT04207047

Histologic Evaluation of Tissue Following Lutronic System Exposure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Abdominoplasty

Interventions

Type	Name	Description
DEVICE	Genius	The Infini Radiofrequency System (K121481) is the predicate device. It is a minimally invasive radiofrequency device that employs a bipolar microneedle electrode system indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The Genius system is substantially equivalent to the Infini device with a digitally controlled direct drive mechanism for needle insertion and an improved needle design for easier needle insertion. The active tip of the Genius system is the substantially equivalent to the Infini device. The handpiece of the Genius system has also been redesigned to be lighter and more ergonomic.
DEVICE	eC02	The eCO2 Laser System (K091115) is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The fractional 90 degree BellaV handpiece is intended to provide fractional CO2 treatment of skin and is not yet cleared.
DEVICE	PicoPlus	The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
DEVICE	LaseMD	The LaseMD Laser System (K171009) is a 1927 factional thulium laser indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles). The cleared LaseMD system is a 5W system.
DEVICE	LaseMD Flex	There are two new versions of the LaseMD system to be used in this study that are uncleared and investigational use only. The only change from the cleared system to the one of the LaseMD systems to be used in this study is that the watts have been increased to 20W and a new tip configuration with a larger 250+ um spot size. The other LaseMD system to be used in this study is the LaseMD FLEX. It also has 20W with larger spot size, a modified flat-top beam profile (as opposed to a Gaussian beam profile) and a faster scan rate. All other technical specifications remain the same as the cleared device.

Timeline

• Start date: 2018-10-02
• Primary completion: 2018-10-31
• Completion: 2020-03-31
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study