Status:
COMPLETED
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Lead Sponsor:
Cynosure, Inc.
Conditions:
Skin Laxity
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
Detailed Description
Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a cont...
Eligibility Criteria
Inclusion
- • Subject has completed their participation in the CYN20-FIRM-LIPO study.
Exclusion
- The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04881149
Start Date
February 12 2021
End Date
March 10 2021
Last Update
June 1 2022
Active Locations (1)
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1
JUVA Skin & Laser Center
New York, New York, United States, 10022