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

This study has been terminated.

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

Sponsor:

Information provided by:

Cutera Inc.

ClinicalTrials.gov Identifier:

NCT00953160

First received: August 4, 2009

Last updated: March 16, 2011

Last verified: March 2011

History of Changes

Results First Received: February 25, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cellulite
Intervention:	Device: Cutera Radio Frequency Device

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study subjects were recruited in the medical clinic 01/01/09 through 01/13/10.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Radiofrequency (RF) Treatment	Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)

Participant Flow: Overall Study

	Radiofrequency (RF) Treatment
STARTED	76
COMPLETED	49
NOT COMPLETED	27
Lost to Follow-up	23
Withdrawal by Subject	4

Baseline Characteristics

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Reporting Groups

	Description
Radiofrequency (RF) Treatment	Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)

Baseline Measures

	Radiofrequency (RF) Treatment
Number of Participants [units: participants]	76
Age [units: participants]
<=18 years	0
Between 18 and 65 years	76
>=65 years	0
Age [units: years] Mean ± Standard Deviation	43 ± 8.5
Gender [units: participants]
Female	69
Male	7
Region of Enrollment [units: participants]
United States	76

Outcome Measures

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1. Primary:

Change in Circumference (cm) [ Time Frame: Baseline and 6 months post final treatment ]

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Measure Type	Primary
Measure Title	Change in Circumference (cm)
Measure Description	No text entered.
Time Frame	Baseline and 6 months post final treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Radiofrequency (RF) Treatment	Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)

Measured Values

	Radiofrequency (RF) Treatment
Number of Participants Analyzed [units: participants]	49
Change in Circumference (cm) [units: Centimeters (cm)] Mean ± Standard Deviation
Abdomen	-0.5 ± 2.2
Thigh	0.6 ± 4.7
Flank	-1.4 ± 2.1

No statistical analysis provided for Change in Circumference (cm)

2. Secondary:

Subject Satisfaction [ Time Frame: Baseline and 6 months post final treatment ]

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3. Secondary:

The Number of Participants With Adverse Events [ Time Frame: Up to 6 months after the last treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: "The Doctor will not publish or present the results of the Study, or speak publicly about it, unless Cutera has first had a reasonable opportunity to review and comment on the contents of the proposed presentation or publication."

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of the study resulting in analysis of small numbers of subjects, and technical issues with repeatability and reproducibility of circumference measurements leading to termination.

Results Point of Contact:

Name/Title: Ayse Turley, Clinical Development Researcher
Organization: Cutera Inc.
phone: 415-657-5665
e-mail: aturley@cutera.com

No publications provided

Responsible Party:	Stephanie Buech, Director of Clinical Research, Cutera Inc.
ClinicalTrials.gov Identifier:	NCT00953160 History of Changes
Other Study ID Numbers:	C-09-TF-02
Study First Received:	August 4, 2009
Results First Received:	February 25, 2011
Last Updated:	March 16, 2011
Health Authority:	United States: Institutional Review Board

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