CompletedNCT03433417Updated Mar 17, 2023Results posted

Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

An interventional study of Cutera truSculpt in Body Fat, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 24 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Cutera Inc. · Not applicable, Interventional, and Basic science

From the registry’s dates

Registered 7 months after the study started (first participant enrolled Jun 2017, registered Feb 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 12
Allocation: Non-randomized
Ages: 24 Years to 60 Years
Sex: All

Study summary

Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

Read the detailed description

A single-center, prospective, non-randomized, open-label study to evaluate the truSculpt Radiofrequency Device for non-invasive fat reduction in abdominal tissue for up to 14 subjects. Measurement will be histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control.

Conditions studied

Body Fat

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.

Browse Cutera Inc. studies →

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

Who can participate

Ages eligible: 24 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or Female, 24 to 60 years of age (inclusive)
Fitzpatrick Skin Type I - VI (Appendix 3)
Has visible fat bulges or skin laxity in the abdominal region
Scheduled to undergo surgery (abdominoplasty).
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 region during the study period.
Subject must be able to read, understand and sign the Form.
Subject must adhere to the follow-up schedule and study instructions.
Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study.
Willing to provide histology samples during the surgery from the intended to be harvested areas.
or surgically sterilized, or using a medically acceptable form of 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:

Participation in a clinical trial of another device or drug in the target area 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.
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.
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 in the treatment area.
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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Single group
Masking: Single (Outcomes assessor)
Enrollment: 12 participants (actual)

Study arms

Experimental
Treatment Side
One truSculpt treatment
Device: Cutera truSculpt
No intervention
Control Side
Untreated contralateral control

Interventions

DeviceCutera truSculpt
One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty

What researchers measure

Primary outcomes

Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response
Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response.
Time frame: 0 to 90 days

Results

Posted Mar 17, 2023

Participant flow

Participant flow — Overall Study
Milestone	All Study Participants
Started	12
Treatment with trusculpt device	12
No treatment with trusculpt device	12
Completed	12
Not completed	0

Outcome measures

PrimaryNumber of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response

Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response.

Time frame:: 0 to 90 days
Reported as:: Count of participants · Participants

Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response
Participants	All Study Participants - Treatment Side	All Study Participants - Untreated Bilateral Control Side
Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response	10	0

Adverse events

Collected over 90 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment Side	0/12 (0%)	0/12 (0%)	12/12 (100%)
Control Side	0/12 (0%)	0/12 (0%)	0/12 (0%)

Most frequent other events

Most frequent other events
Event	Treatment Side	Control Side
ErythemaSkin and subcutaneous tissue disorders	12/12	0/12
EdemaSkin and subcutaneous tissue disorders	12/12	0/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	All Study Participants
<=18 years	0
Between 18 and 65 years	12
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	11
Male	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Study Participants
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	9
More than one race	0
Unknown or Not Reported	0

Study locations

1 site

Cutera Research Center
Brisbane, California 94005, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jul 6, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Mar 2018, 9 months.

Results were first posted in Mar 2023, 5 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 5, 2018
First posted: Feb 14, 2018
StartActual: Jun 15, 2017
Primary completionActual: Mar 15, 2018
CompletionActual: Mar 15, 2018
Results first posted: Mar 17, 2023
Last update: Mar 17, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03433417
Lead sponsor: Cutera Inc.
Responsible party: Sponsor
First posted: Feb 14, 2018
Start date: Jun 15, 2017
Primary completion: Mar 15, 2018
Completion: Mar 15, 2018
Results posted: Mar 17, 2023
Last update: Mar 17, 2023

Study contacts

Stephen Ronan, MD

principal investigator · Cutera Research Center

Oversight

FDA-regulated drug: No
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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