Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees

November 21, 2017 updated by: Ulthera, Inc

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, aged 30 to 65 years.
  • Subject in good health.
  • Mild to moderate skin laxity around the knees.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Excessive subcutaneous fat around the knees.
  • Excessive skin laxity around the knees.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulthera® treatment of the knees
Bilateral treatment of the knees using the Ulthera® System
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ultherapy™ treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in overall lifting and tightening of knee skin laxity.
Time Frame: 90 and 180 days post-treatment
Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
90 and 180 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall improvement in skin laxity.
Time Frame: 90 and 180 days post-treatment
Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.
90 and 180 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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