CelluliteNCT00953160
Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body
A study testing Cutera Radio Frequency Device in people with Cellulite, run by Cutera Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cellulite
- 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
- 76 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2009to Jul 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Blackhawk Plastic Surgery
Danville, California, 94506
Renu LaserSpa
Dublin, California, 94568
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, 37203
Calkin/Boudreaux Dermatology Associates
Sacramento, California, 95825-6372
About this study
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
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.
Read the 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.
- Conditions
- Cellulite
- Being tested
- Cutera Radio Frequency Device
- Keywords
- Cellulite, Adipose tissue, Circumference, Reduction, Thigh, Abdomen, Flank
- 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 group | Role | What they receive |
|---|---|---|
| RF treatment | Experimental | Abdomen, flank or thigh treated with RF device Receives: Device: Cutera Radio Frequency Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circumference (cm)
Measured: Baseline and 6 months post final treatment
Secondary outcomes (2)
Subject Satisfaction
Measured: Baseline and 6 months post final treatment
The Number of Participants With Adverse Events
At each visit (treatment and follow-up) or until resolution of AEs
Measured: Up to 6 months after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: The preliminary data from this pilot study 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 CelluliteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Biesman, MD, Principal investigatorJacqueline Calkin, MD, Principal investigatorStephen Ronan, MD, Principal investigatorScott Kramer, MD, Principal investigatorAdele Makow, MD, Principal investigatorBarry DiBernardo, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953160
- Sponsor's protocol ID
- C-09-TF-02
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2009
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00953160
- Acronym / sponsor ID
- C-09-TF-02
- Conditions
- Cellulite
- Keywords
- Cellulite, Adipose tissue, Circumference, Reduction, Thigh, Abdomen, Flank
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The preliminary data from this pilot study did not indicate efficacy.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 17 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF treatment | Experimental | Device: Cutera Radio Frequency DeviceAbdomen, flank or thigh treated with RF device |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
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 | RF treatment |
Primary outcome
Change in Circumference (cm)
Time frame: Baseline and 6 months post final treatment
2 secondary outcomes
Subject Satisfaction
Time frame: Baseline and 6 months post final treatment
The Number of Participants With Adverse Events
Time frame: Up to 6 months after the last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian Biesman, MD principal investigator
Jacqueline Calkin, MD principal investigator
Stephen Ronan, MD principal investigator
5 sites 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 Cellulite, run by Cutera Inc. at 5 sites 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 9 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 17 Mar 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?
Change in Circumference (cm) (time frame: Baseline and 6 months post final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2023.