The PREFORM Study: Rotational Fractional Resection for Submental Contouring

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

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-10-16

Brief Summary

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This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.

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Detailed Description

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This is a prospective, single-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Conditions

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Skin Laxity Lipodystrophy

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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Rotational fractional resection (1.5mm Diameter Device)

Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Group Type EXPERIMENTAL

Rotational fractional resection (1.5mm Diameter Device)

Intervention Type DEVICE

Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Interventions

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Rotational fractional resection (1.5mm Diameter Device)

Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female
* At least 30 years old
* Moderate to severe submental laxity
* Up to moderate submental lipodystrophy
* Agree to maintain weight (±5%) for the duration of the study

Exclusion Criteria

* Previous intervention to treat submental fat or skin laxity
* Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
* Severe acne, cystic acne or acne scars on neck
* Trauma of chin or neck area
* Skin infection or rash on neck
* Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
* History of scarring
* Body mass index (BMI) \>30
* Clinically significant bleeding disorder
* Anemia, kidney disease, or liver disease

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes