Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks

Cynosure

Status: Completed

Conditions: Skin Laxity

Treatments: Device: TempSure treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04881149

CYN20-FIRM-LIPO-ROLLOVER

Details and patient eligibility

About

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.

Full 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 control.

Enrollment: 7 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed their participation in the CYN20-FIRM-LIPO study.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

All Study Participants

Experimental group

Description:

The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).

Treatment:

Device: TempSure treatment