Tissue TighteningNCT03018587

Feasibility Study of the TruSculpt Radiofrequency Device

A study testing TruSculpt in people with Tissue Tightening, run by Cutera Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Tissue Tightening
What is being tested?: TruSculpt
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 29 Dec 2017
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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or Female, 18 to 70 years of age (inclusive)
Fitzpatrick Skin Type I - VI
Has visible fat bulges,skin laxity, or cellulite in the treatment area
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 treatment area during the study period.
Subject must be able to read, understand and sign the Informed Consent Form.

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Subject must adhere to the follow-up schedule and study instructions.
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 in the target area during the study period.
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 that is local to the treatment area, 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.
Diagnosed or documented immune system disorders.
History of any disease or condition that could impair wound healing.

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History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
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.

United States1 site

Cutera Research Center
Brisbane, California, 94005

Other trials in United States

About this study

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.

Read the detailed description

A single-center, prospective, open-label study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.

Conditions: Tissue Tightening
Being tested: TruSculpt

What participants receive

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

TruSculptDevice
All subjects will receive 1 truSculpt radiofrequency treatment

Study groups in NCT03018587
Study group	Role	What they receive
All subjects	Experimental	All subjects will receive 1 truSculpt radiofrequency treatment in desired area. Receives: Device: TruSculpt

What is being measured

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

Investigator Assessment of Improvement
Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (<5%)
Measured: 12 weeks post-treatment

Timeline

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

Jan 201729 Dec 2017

First posted12 Jan 2017 (estimated)
Study startJan 2017
Primary completionDec 2017
Study completion29 Dec 2017

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 Tissue TighteningStudies 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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03018587
Sponsor's protocol ID: C-16-TS12
Status last verified: Feb 2023
First submitted: 9 Jan 2017
Last updated: 7 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated device: Yes
Individual data sharing: No: None. No individual participant data will be shared with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tissue Tightening trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of the TruSculpt Radiofrequency Device
ClinicalTrials.gov ID: NCT03018587
Acronym / sponsor ID: C-16-TS12
Conditions: Tissue Tightening
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: Jan 2017 (actual)
Primary completion: Dec 2017 (actual)
Study completion: 29 Dec 2017 (actual)
First posted: 12 Jan 2017 (estimated)
Results: Posted 7 Mar 2023

Clinical summary

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

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.

Detailed description

A single-center, prospective, open-label study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects	Experimental	Device: TruSculptAll subjects will receive 1 truSculpt radiofrequency treatment in desired area.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or Female, 18 to 70 years of age (inclusive)
Fitzpatrick Skin Type I - VI
Has visible fat bulges,skin laxity, or cellulite in the treatment area
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 treatment area during the study period.

Key exclusion criteria (11 listed)

Participation in a clinical trial of another device or drug in the target area during the study period.
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 that is local to the treatment area, 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.
Diagnosed or documented immune system disorders.

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
TruSculptAll subjects will receive 1 truSculpt radiofrequency treatment	Device	All subjects

Primary outcome

Investigator Assessment of Improvement
Time frame: 12 weeks post-treatment
Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (<5%)

Results and safety

Results posted to the registry on 7 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	23	19

Primary outcome: Investigator Assessment of Improvement

Time frame: 12 weeks post-treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	All Subjects n = 18
Value	0.67 (0.47)

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 23 (0%)	23 of 23 (100%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. None. No individual participant data will be shared with other researchers.

Related trials for Tissue Tightening

Active, not recruiting
Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity
Laxity; Skin
Not yet recruiting
Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas
Skin Laxity (Submental and Neck), Skin Lifting and Tightening
Recruiting
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
Skin Laxity
Recruiting
Effects of QUANTUM Probe for Skin Rejuvenation and Subdermal Retraction in Patients Undergoing High-Definition Liposculpture
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RecruitingPhase 3
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Diffuse Cutaneous Systemic Sclerosis

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 Ronan, M.D. principal investigator

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 TruSculpt in people with Tissue Tightening, 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 9 inclusion and 11 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 7 Mar 2023. 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 7 Mar 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?

Investigator Assessment of Improvement (time frame: 12 weeks post-treatment). 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 NCT03018587.

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 7 Mar 2023.