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CompletedNCT03018587Updated Mar 7, 2023Results posted

Feasibility Study of the TruSculpt Radiofrequency Device

An interventional study of TruSculpt in Tissue Tightening, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tissue Tightening
03

In context

Lead sponsor

Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or Female, 18 to 70 years of age (inclusive)
  2. Fitzpatrick Skin Type I - VI
  3. Has visible fat bulges,skin laxity, or cellulite in the treatment area
  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 area during the study period.
  6. Subject must be able to read, understand and sign the Informed Consent Form.
  7. Subject must adhere to the follow-up schedule and study instructions.
  8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug in the target area during the study period.
  2. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
  3. 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.
  4. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
  5. Diagnosed or documented immune system disorders.
  6. History of any disease or condition that could impair wound healing.
  7. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
  8. Infection, dermatitis, rash or other skin abnormality in the target area.
  9. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
  10. Pregnant or currently breastfeeding.
  11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    All subjects

    All subjects will receive 1 truSculpt radiofrequency treatment in desired area.

    Device: TruSculpt

Interventions

  • DeviceTruSculpt

    All subjects will receive 1 truSculpt radiofrequency treatment

06

What researchers measure

Primary outcomes

  1. 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%)

    Time frame: 12 weeks post-treatment

07

Results

Posted Mar 7, 2023

Participant flow

Participant flow — Overall Study
MilestoneAll Subjects
Started23
Completed19
Not completed4

Outcome measures

PrimaryInvestigator 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%)

Time frame:
12 weeks post-treatment
Reported as:
Mean · score on a scale
Investigator Assessment of Improvement
score on a scaleAll Subjects
Investigator Assessment of Improvement0.67 ± 0.47

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Subjects0/23 (0%)0/23 (0%)23/23 (100%)
Most frequent other events
Most frequent other events
EventAll Subjects
ErythemaSkin and subcutaneous tissue disorders21/23
NodulesSkin and subcutaneous tissue disorders14/23
EdemaSkin and subcutaneous tissue disorders11/23
Post treatment pain/discomfortSkin and subcutaneous tissue disorders6/23
PurpuraSkin and subcutaneous tissue disorders4/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Subjects
<=18 years0
Between 18 and 65 years23
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female19
Male4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Subjects
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander2
Black or African American0
White12
More than one race0
Unknown or Not Reported4
Visible fat bulges, skin laxity, or cellulite
Visible fat bulges, skin laxity, or cellulite(Participants)All Subjects
Count of participants23
08

Study locations

1 site
  • Cutera Research Center
    Brisbane, California 94005, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 5, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — None. No individual participant data will be shared with other researchers.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03018587
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Jan 12, 2017
Start date
Jan 2017
Primary completion
Dec 2017
Completion
Dec 29, 2017
Results posted
Mar 7, 2023
Last update
Mar 7, 2023

Study contacts

Stephen Ronan, M.D.
principal investigator · Principal Investigator

Oversight

FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Cutera Inc.

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