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Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

NCT ID: NCT01708499

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-04-30

Brief Summary

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Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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 for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Conditions

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Skin Laxity Skin Crepiness

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

SINGLE

Outcome Assessors

Study Groups

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Study treatment

All enrolled subjects will receive one Ulthera System Treatment.

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, aged 25 to 60 years.
* Subject in good health.
* Skin laxity in the abdomen
* 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 abdomen.
* Excessive skin laxity on the abdomen.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Inability to understand the protocol or to give informed consent.
* BMI equal to and greater than 30.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 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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Gordon Sasaki, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Sasaki Advanced Aesthetic Medical Center

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-128

Identifier Type: -

Identifier Source: org_study_id