Body FatNCT01665118
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
A study testing Trusculpt (Radio Frequency) Device in people with Body Fat, run by Cutera Inc. at 3 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Fat
- What is being tested?
- Trusculpt (Radio Frequency) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Jun 2013
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 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 and/or no plans to become pregnant for the duration of the study.
- Body Mass Index (BMI) ≤ 30
- Visible fat in the thigh / saddlebag area to be treated
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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 the weight measure at the baseline assessment)
Who cannot join
- Taking weight-loss medications/supplements
- Simultaneous participation in any other clinical study
- Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
- Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
- Arteriosclerosis or weakened blood vessels
- Heart disease
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- Thromboembolic disease
- Diagnosed or documented immune system disorders (including Panniculitis)
- Bleeding disorders
- Presence of uncontrolled hypertension
- Taking prescription anticoagulants
- History of keloid formation
- History of 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) or metallic implants
- Pregnant or lactating
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cutera Research Center
Brisbane, California, 94005
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, 37203
About this study
Official title: The Cutera Trusculpt Device For Thigh Circumference Reduction
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
Read the detailed description
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
- Conditions
- Body Fat
- Being tested
- Trusculpt (Radio Frequency) Device
- Keywords
- Radio frequency, thigh, circumference, reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trusculpt (Radio Frequency) DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Treated Thigh | Experimental | Trusculpt (Radio Frequency) Device Receives: Device: Trusculpt (Radio Frequency) Device |
| Untreated Contra-lateral Thigh | No intervention | To be used as the self control in this split body study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Thigh Circumference From Baseline
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Measured: Comparison of Baseline to 12 weeks post- final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionJun 2013
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 Body 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Biesman, MD, Principal investigatorBarry DiBernardo, MD, Principal investigatorStephen Ronan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665118
- Sponsor's protocol ID
- C-12-TS05
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2012
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cutera Trusculpt Device For Thigh Circumference Reduction
- ClinicalTrials.gov ID
- NCT01665118
- Acronym / sponsor ID
- C-12-TS05
- Conditions
- Body Fat
- Keywords
- Radio frequency, thigh, circumference, reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
Detailed description
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
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: Trusculpt (Radio Frequency) DeviceTrusculpt (Radio Frequency) Device |
| Untreated Contra-lateral Thigh | No intervention | –To be used as the self control in this split body study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- 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 and/or no plans to become pregnant for the duration of the study.
- Body Mass Index (BMI) ≤ 30
Key exclusion criteria (19 listed)
- Taking weight-loss medications/supplements
- Simultaneous participation in any other clinical study
- Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
- Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
- Arteriosclerosis or weakened blood vessels
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 |
|---|---|---|
| Trusculpt (Radio Frequency) Device | Device | Treated Thigh |
Primary outcome
Change of Thigh Circumference From Baseline
Time frame: Comparison of Baseline to 12 weeks post- final treatment
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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
Barry DiBernardo, MD principal investigator
Stephen Ronan, MD principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trusculpt (Radio Frequency) Device in people with Body Fat, run by Cutera Inc. at 3 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 19 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 21 Feb 2023). 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 of Thigh Circumference From Baseline (time frame: Comparison of Baseline to 12 weeks 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 21 Feb 2023.