An interventional study of Cutera truSculpt Device in Treatment for Cellulite on the Stomach and Flanks, sponsored by Cutera Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 34 is close to the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →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.
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.
Subject must be able to read, understand and sign the Form.
Exclusion Criteria:
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.
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.
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).
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated with the truSculpt RF device
Device: Cutera truSculpt Device
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.
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 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement
Time frame: 12 weeks post final treatment
| Milestone | Treatment With the truSculpt RF Device |
|---|---|
| Started | 34 |
| Completed | 30 |
| Not completed | 4 |
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
| score on a scale | Treatment With the truSculpt RF Device |
|---|---|
| GAIS at 12 Weeks Post Final Treatment | 2 ± 0.94 |
Collected over up to 12 weeks post final treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With the truSculpt RF Device | 0/34 (0%) | 0/34 (0%) | 22/34 (64.7%) |
| Event | Treatment With the truSculpt RF Device |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 22/34 |
| EdemaSkin and subcutaneous tissue disorders | 2/34 |
| Age, Categorical(Participants) | Treatment With the truSculpt RF Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment With the truSculpt RF Device |
|---|---|
| Female | 30 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With the truSculpt RF Device |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
Plan to share: Yes — Researchers involved in the study will have access to the final study data.
Supporting information: Study protocol, Informed consent form, Clinical study report
Ran from May 2018 to primary completion in Dec 2018, 7 months.
Results were first posted in Sep 2023, 4 years 8 months after primary completion.
Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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