Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT01713569
Status:
TERMINATED
Last Update Posted:
2017-11-24
First Post:
2012-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
Sponsor:
Ulthera, Inc
Organization:
Study Overview
Official Title:
Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow subject enrollment; study to be obtained is no longer required.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: