NCT00953290|TerminatedResults
Study Stopped
The study was terminated because the preliminary data did not indicate efficacy.
Thigh Circumference Reduction Study
Cutera Radio Frequency Device for Thigh Circumference Reduction
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Sponsor study identifier
interventional
4
1 country
1
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 4, 2009
Actual (reported)August 6, 2009
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)April 18, 2011
Actual (reported)Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]
Baseline and 6 months post final treatment
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]
Baseline and 6 months post final treatment
Subject Satisfaction
Baseline and 6 months post final treatment
Adverse Events
At each visit (treatment and follow-up) or until resolution of AEs
The thigh treated with the RF device
The untreated thigh
Up to three treatments, one pass, dosage range of 15-60 kJ.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Blackhawk Plastic Surgery
Danville, California, 94506, United States
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.
Stephen J. Ronan, MD
Jacqueline Calkin, MD
Christine Lee, MD
Scott Kramer, MD
4 participants (actual enrollment reported by the registry).
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
May 10, 2011
Results First Posted
April 18, 2011
Record last verified: 2011-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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