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Simulines Non-Inferiority Pivotal Study

NCT02736825 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2020-02-19

Study results available
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Summary

Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

Conditions

  • Skin Laxity

Interventions

DEVICE

Ulthera System with standard transducer

Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time

DEVICE

Ulthera System with prototype 2 simulines transducer

Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Kari Larson, MBA · Ulthera, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-11
Primary Completion
2017-01-20
Completion
2017-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736825 on ClinicalTrials.gov