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Clinical Trial Summary

A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.


Clinical Trial Description

This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02763306
Study type Interventional
Source R2 Dermatology
Contact
Status Completed
Phase N/A
Start date June 2015
Completion date April 2017

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