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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skin Laxity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Study Participants

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).

Group Type EXPERIMENTAL

TempSure treatment

Intervention Type DEVICE

Self-controlled, single-arm study using the TempSure device.

Interventions

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TempSure treatment

Self-controlled, single-arm study using the TempSure device.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No