MedDataX Logo

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

NCT ID: NCT01708434

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Laxity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Skin laxity Knees

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ulthera® treatment of the knees

Bilateral treatment of the knees using the Ulthera® System

Group Type EXPERIMENTAL

Ulthera® System

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ulthera® System

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ultherapy™ treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Clinical Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). J Cosmet Laser Ther. 2014 Oct;16(5):225-9. doi: 10.3109/14764172.2014.949273. Epub 2014 Sep 2.

Reference Type DERIVED
PMID: 25065380 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ULT-115

Identifier Type: -

Identifier Source: org_study_id