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Feasibility Study: Lifting and Tightening of the Elbows

NCT ID: NCT01708382

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-02-28

Brief Summary

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Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

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This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Conditions

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Skin Laxity

Keywords

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Ulthera® System Ultherapy™ Treatment Ulthera, Inc. Ultrasound treatment for skin tightening

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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Ultherapy treatment on the elbows

All enrolled subjects will receive one Ultherapy treatment to the elbows.

Group Type EXPERIMENTAL

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Interventions

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Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 21 to 65 years.
* Subject in good health.
* Mild to moderate skin laxity on the elbows.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Excessive subcutaneous fat around the elbows.
* Excessive skin laxity around the elbows.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the area to be treated
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cameron K Rokhsar, MD

Role: PRINCIPAL_INVESTIGATOR

New York Cosmetic, Skin, and Laser Surgery Center

Locations

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New York Cosmetic, Skin and Laser Surgery Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-108

Identifier Type: -

Identifier Source: org_study_id