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Study of the Cabochon System for Improvement in the Appearance of Cellulite

NCT ID: NCT01671839

Last Updated: 2019-12-10

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.

Detailed Description

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Conditions

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Gynoid Lipodystrophy

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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Subcutaneous tissue release

Device: Subcutaneous tissue release with the Cabochon System

Group Type EXPERIMENTAL

Subcutaneous tissue release with the Cabochon System

Intervention Type DEVICE

Device: Subcutaneous tissue release

Interventions

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Subcutaneous tissue release with the Cabochon System

Device: Subcutaneous tissue release

Intervention Type DEVICE

Other Intervention Names

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Cellfina®

Eligibility Criteria

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Inclusion Criteria

* Female, age 18-55
* moderate or severe cellulite
* BMI less than 35
* will not to try any other cellulite treatments through 12M follow-up


* Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
* Subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up

Exclusion Criteria

* cellulite treatment on the thighs or buttocks in the last 90 days
* prior liposuction in the thighs or buttocks
* Greater than 10% increase or decrease in body weight within past 6 months
* evidence of active infection or a fever \>38C
* current or recent smoker
* history of hypertension, diabetes or hypoglycemia
* history of coagulopathy(ies) and/or on anticoagulant medication
* history of cardiopathy or pneumopathy
* history of severe anemia
* has atrophic scars, or has a history of atrophic scars or keloids
* taken within 14 days of treatment:

* NSAIDs (e.g. aspirin, ibuprofen, naproxen)
* Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark)
* Herbal Teas
* Subject is pregnant or lactating

For Extended Follow-Up the following apply:


* Subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit.
* Subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role collaborator

Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Kaminer

Role: PRINCIPAL_INVESTIGATOR

Skin Care Physicians

Locations

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The Coleman Center for Cosmetic and Dermatologic Surgery

Metairie, Louisiana, United States

Site Status

Maryland Laser Skin & Vein Institute

Hunt Valley, Maryland, United States

Site Status

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CP-01-1004

Identifier Type: -

Identifier Source: org_study_id