Treatment for Cellulite on the Stomach and FlanksNCT03782545
Multi-Center Pilot Study of Cutera truSculpt Device
A study testing Cutera truSculpt Device in people with Treatment for Cellulite on the Stomach and Flanks, run by Cutera Inc. at 3 sites in United States.
Trial summary
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment for Cellulite on the Stomach and Flanks
- What is being tested?
- Cutera truSculpt Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2018to 19 Dec 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Subject must be able to read, understand and sign the Informed Consent Form.
- 2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- 5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
- 6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
- 8. Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
- 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.
Who cannot join
- Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation.
- Any prior invasive cosmetic surgery to the target area, such as liposuction.
- 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 artificial heart valves.
- Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
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- History of any disease or condition that could impair wound healing.
- History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
- Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
- Allergy or sensitivity to Tegaderm.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advanced Dermatology
Glencoe, Illinois, 60022
Union Square Dermatology
New York, New York, 10003
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Read the detailed description
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
- Being tested
- Cutera truSculpt Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutera truSculpt DeviceDevice
The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the truSculpt RF device | Experimental | Subjects will be treated with the truSculpt RF device Receives: Device: Cutera truSculpt Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAIS at 12 Weeks Post Final Treatment
Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change
- Mild Improvement
- Moderate improvement
- Significant Improvement
Measured: 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 posted20 Dec 2018
- Study start11 May 2018
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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 Treatment for Cellulite on the Stomach and FlanksStudies 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
- Model description
- A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT03782545
- Sponsor's protocol ID
- C-18-TS-18
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2018
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Researchers involved in the study will have access to the final study data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Pilot Study of Cutera truSculpt Device
- ClinicalTrials.gov ID
- NCT03782545
- Acronym / sponsor ID
- C-18-TS-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Detailed description
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment with the truSculpt RF device | Experimental | Device: Cutera truSculpt DeviceSubjects will be treated with the truSculpt RF device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Subject must be able to read, understand and sign the Informed Consent Form.
- 2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- 5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
- 6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
- 8. Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
Key exclusion criteria (12 listed)
- Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation.
- Any prior invasive cosmetic surgery to the target area, such as liposuction.
- 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 artificial heart valves.
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 truSculpt DeviceThe Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite. | Device | Treatment with the truSculpt RF device |
Primary outcome
GAIS at 12 Weeks Post Final Treatment
Time frame: 12 weeks post final treatment
Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Researchers involved in the study will have access to the final study data.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutera truSculpt Device in people with Treatment for Cellulite on the Stomach and Flanks, 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 6 inclusion and 12 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 13 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 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 13 Sep 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?
GAIS at 12 Weeks Post Final Treatment (time frame: 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 13 Sep 2023.