Reduction of Localized Excess FatNCT00953290

Thigh Circumference Reduction Study

A study testing Cutera Radio Frequency Device in people with Reduction of Localized Excess Fat, run by Cutera Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Reduction of Localized Excess Fat
What is being tested?: Cutera Radio Frequency Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Jan 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Body Mass Index between 20 and 35
Presence of cellulite grades II, III or IV according to GLD scale
Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm 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

Who cannot join

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

Show all 21Show fewer

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
Infection in the target area
Implanted electrical device(s)
Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

United States1 site

Blackhawk Plastic Surgery
Danville, California, 94506

Other trials in United States

About this study

Official title: Cutera Radio Frequency Device for Thigh Circumference Reduction

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Read the detailed description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Conditions: Reduction of Localized Excess Fat
Being tested: Cutera Radio Frequency Device
Keywords: Cellulite, Adipose tissue, Circumference, Reduction, Thigh
Medical subject headings: Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cutera Radio Frequency DeviceDevice
Also called Callisto, TruForm, TruSculpt
Up to three treatments, one pass, dosage range of 15-60 kJ.

Study groups in NCT00953290
Study group	Role	What they receive
Treated Thigh	Experimental	The thigh treated with the RF device Receives: Device: Cutera Radio Frequency Device
Untreated Thigh	No intervention	The untreated thigh

What is being measured

The primary outcome is the main question the study is designed to answer.

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]
Measured: 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]
Measured: Baseline and 6 months post final treatment

Secondary outcomes (2)

Subject Satisfaction
Measured: Baseline and 6 months post final treatment
Adverse Events
Measured: At each visit (treatment and follow-up) or until resolution of AEs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jan 2010

First posted6 Aug 2009 (estimated)
Study startJan 2009
Primary completionJan 2010
Study completionJan 2010

Why it stopped: The study was terminated because the preliminary data did not indicate efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Reduction of Localized Excess FatStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00953290
Sponsor's protocol ID: CTCS002
Status last verified: May 2011
First submitted: 4 Aug 2009
Last updated: 10 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cutera Radio Frequency Device for Thigh Circumference Reduction
ClinicalTrials.gov ID: NCT00953290
Acronym / sponsor ID: CTCS002
Conditions: Reduction of Localized Excess Fat
Keywords: Cellulite, Adipose tissue, Circumference, Reduction, Thigh
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because the preliminary data did not indicate efficacy.
Enrolment: 4 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 18 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Detailed description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treated Thigh	Experimental	Device: Cutera Radio Frequency DeviceThe thigh treated with the RF device
Untreated Thigh	No intervention	–The untreated thigh

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Body Mass Index between 20 and 35
Presence of cellulite grades II, III or IV according to GLD scale
Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm 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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cutera Radio Frequency DeviceAlso: Callisto, TruForm, TruSculptUp to three treatments, one pass, dosage range of 15-60 kJ.	Device	Treated Thigh

Primary outcome

Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
Time frame: Baseline and 6 months post final treatment
Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
Time frame: Baseline and 6 months post final treatment
Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]

2 secondary outcomes

Subject Satisfaction
Time frame: Baseline and 6 months post final treatment
Adverse Events
Time frame: At each visit (treatment and follow-up) or until resolution of AEs

Results and safety

Results posted to the registry on 18 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated and Untreated Thigh	4	4

Primary outcome: Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms

Time frame: Baseline and 6 months post final treatment. Mean (Standard Deviation). Unit: cm

Measure	Treated and Untreated Upper Thigh n = 4
Value	1.0 (1.7)

Primary outcome: Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms

Time frame: Baseline and 6 months post final treatment. Mean (Standard Deviation). Unit: cm

Measure	Treated and Untreated Mid Thigh n = 4
Value	0.63 (1.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Thigh	0 of 4 (0%)	3 of 4 (75%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen J. Ronan, MD principal investigator

Jacqueline Calkin, MD principal investigator

Christine Lee, MD principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cutera Radio Frequency Device in people with Reduction of Localized Excess Fat, run by Cutera Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms (time frame: Baseline and 6 months post final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00953290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.