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Feasibility Study: Histological Characterization After Treatment With the Ulthera® System

Skin Laxity Clinical Trial

Official title:
Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System

Clinical Trial Summary

Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.

Clinical Trial Description

This study is a prospective, single-center clinical trial. Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. Enrolled subjects will be treated with an assigned transducer based on their order of enrollment. At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01713569
Study type Interventional
Source Merz Pharmaceuticals, LLC
Contact
Status Terminated
Phase N/A
Start date October 2012
Completion date October 2013
View Details
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