Abdominal FatNCT02873104
Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
A study testing truSculpt rf device in people with Abdominal Fat, run by Cutera Inc. at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction. Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat
- What is being tested?
- truSculpt rf device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- 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 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period.
- Subject must be able to read, understand and sign the Informed 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 5% of baseline weight measurement.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
- Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
- Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
- Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
- Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
- Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
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- Diagnosed or documented immune system disorders. History of any disease or condition that could impair wound healing. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
- Infection, dermatitis, rash or other skin abnormality in the target area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
- Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
Read the detailed description
The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera truSculpt RF device for circumferential reduction in the abdominal and flank region.
- Conditions
- Abdominal Fat
- Being tested
- truSculpt rf device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
truSculpt rf deviceDevice
radiofrequency device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | truSculpt rf device, therapeutic settings Receives: Device: truSculpt rf device |
| Sham | Sham comparator | truSculpt rf device, non-therapeutic settings Receives: Device: truSculpt rf device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment
Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement
Measured: 12 weeks
Secondary outcomes (3)
Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals "no change" and 4 equals "Very Significant Improvement".
Measured: 12 weeks
Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals "very dissatisfied" and 5 equals "very satisfied".
Measured: 12 weeks
Subject Discomfort and Pain Levels During Treatment
Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals "No pain" and 10 equals "Worst possible pain".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Abdominal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873104
- Sponsor's protocol ID
- C-16-TS11
- Status last verified
- Feb 2017
- First submitted
- 16 Aug 2016
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
- ClinicalTrials.gov ID
- NCT02873104
- Acronym / sponsor ID
- C-16-TS11
- Conditions
- Abdominal Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
Detailed description
The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera truSculpt RF device for circumferential reduction in the abdominal and flank region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: truSculpt rf devicetruSculpt rf device, therapeutic settings |
| Sham | Sham comparator | Device: truSculpt rf devicetruSculpt rf device, non-therapeutic settings |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period.
- Subject must be able to read, understand and sign the Informed 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 5% of baseline weight measurement.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Key exclusion criteria (10 listed)
- Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
- Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
- Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
- Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
- Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
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 rf deviceradiofrequency device | Device | Sham, Treatment |
Primary outcome
Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment
Time frame: 12 weeks
Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement
3 secondary outcomes
Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Time frame: 12 weeks
Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Time frame: 12 weeks
Subject Discomfort and Pain Levels During Treatment
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing truSculpt rf device in people with Abdominal 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 5 inclusion and 10 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 28 Feb 2018. 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. Some participants in this study may receive a placebo. 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 28 Feb 2018). 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 Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment (time frame: 12 weeks). 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 28 Feb 2018.