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Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

Primary Purpose

Cellulite

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cutera Radio Frequency Device

About this trial

This is an interventional treatment trial for Cellulite focused on measuring Cellulite, Adipose tissue, Circumference, Reduction, Thigh, Abdomen, Flank

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female or Male
Minimum age of 18 years
Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only)
Minimum Body Mass Index of 20
Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper
Subject must be able to read, understand and sign the Consent Form
Subject must adhere to the follow-up schedule and study instructions
Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)

Exclusion Criteria:

Significant weight fluctuation (+/-10 lbs) in the past 6 months
Taking weight-loss medications/supplements
Participation in any other clinical study
Cellulite treatment within 3 months of the treatment
Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
Prior treatment to the target area within the last 12 months
Arteriosclerosis or weakened blood vessels
Heart disease
Thromboembolic disease
Diagnosed or documented immune system disorders
Bleeding disorders.
Presence of uncontrolled hypertension
Taking prescription anticoagulants
History of keloid formation
Malignant tumors in the target area
Diabetes
Any disease or condition that could impair wound healing
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
Infection in the target area
Implanted electrical device(s)
Pregnant or lactating

Sites / Locations

Blackhawk Plastic Surgery
Renu LaserSpa
Calkin/Boudreaux Dermatology Associates
New Jersey Plastic Surgery
Nashville Center for Laser and Facial Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF treatment

Arm Description

Abdomen, flank or thigh treated with RF device

Outcomes

Primary Outcome Measures

Change in Circumference (cm)

Secondary Outcome Measures

Subject Satisfaction

The Number of Participants With Adverse Events

At each visit (treatment and follow-up) or until resolution of AEs

Full Information

NCT ID

NCT00953160

First Posted

August 4, 2009

Last Updated

August 29, 2023

Sponsor

Cutera Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00953160

Brief Title

Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

Official Title

Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

The preliminary data from this pilot study did not indicate efficacy.

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cutera Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.

Detailed Description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm. At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cellulite

Keywords

Cellulite, Adipose tissue, Circumference, Reduction, Thigh, Abdomen, Flank

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RF treatment

Arm Type

Experimental

Arm Description

Abdomen, flank or thigh treated with RF device

Intervention Type

Device

Intervention Name(s)

Cutera Radio Frequency Device

Other Intervention Name(s)

Callisto, TruForm, TruSculpt

Intervention Description

Up to three treatments, one pass, dosage range of 15-60 kJ.

Primary Outcome Measure Information:

Title

Change in Circumference (cm)

Time Frame

Baseline and 6 months post final treatment

Secondary Outcome Measure Information:

Title

Subject Satisfaction

Time Frame

Baseline and 6 months post final treatment

Title

The Number of Participants With Adverse Events

Description

At each visit (treatment and follow-up) or until resolution of AEs

Time Frame

Up to 6 months after the last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female or Male Minimum age of 18 years Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study. Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only) Minimum Body Mass Index of 20 Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper Subject must be able to read, understand and sign the Consent Form Subject must adhere to the follow-up schedule and study instructions Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight) Exclusion Criteria: Significant weight fluctuation (+/-10 lbs) in the past 6 months Taking weight-loss medications/supplements Participation in any other clinical study Cellulite treatment within 3 months of the treatment Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction Prior treatment to the target area within the last 12 months Arteriosclerosis or weakened blood vessels Heart disease Thromboembolic disease Diagnosed or documented immune system disorders Bleeding disorders. Presence of uncontrolled hypertension Taking prescription anticoagulants History of keloid formation Malignant tumors in the target area Diabetes Any disease or condition that could impair wound healing Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles Infection in the target area Implanted electrical device(s) Pregnant or lactating

Overall Study Officials: