MedDataX Logo

Evaluation of the Ulthera® System for Treatment of the Brachia

NCT ID: NCT01713933

Last Updated: 2017-12-11

Study Results

Results available

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

View full results

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 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 is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Conditions

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

Brachial Ptosis

Keywords

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

Ulthera® System Ultherapy™ treatment Ulthera, Inc.

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.

Ultherapy™ treatment

Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms

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 Ulthera, Inc. Ultrasound treatment for skin tightening

Eligibility Criteria

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

Inclusion Criteria

* Male or female, aged 19 - 55 years.
* Subject in good health.
* Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
* Mild to moderate laxity of the upper arm.
* Mild to moderate subcutaneous fat of the upper arm.
* Mild crepiness of the skin of the upper arm.
* 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.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the upper arm.
* Excessive skin laxity in the upper arm.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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.

Gordon Sasaki, MD FACS

Role: PRINCIPAL_INVESTIGATOR

Sasaki Advanced Aesthetic Medical Center

Locations

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

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, United States

Site Status

Countries

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

United States

Other Identifiers

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

ULT-114

Identifier Type: -

Identifier Source: org_study_id