Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

NCT ID: NCT01693055

Last Updated: 2014-04-07

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

Brief Summary

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Study title

* Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
* single arm and Investigator Initiative pilot study

Detailed Description

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Conditions

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Orbital Fat Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UltheraTM

UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe

Group Type EXPERIMENTAL

UltheraTM 100 shots

Intervention Type DEVICE

UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe

Interventions

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UltheraTM 100 shots

UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>20 years, Age \< 50 years
* people who want to improve baggy eyelid
* Information consent obtained

Exclusion Criteria

* previous lower eyelid surgical history
* scar on lower eyelid after trauma
* bleeding tendency
* aesthetic addiction, drug abuse, alcohol abuse
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chan-Yeong Heo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chanyeong Heo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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L-2012-408-3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E-1207/162-004

Identifier Type: -

Identifier Source: org_study_id

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