An interventional study of Cutera Radio Frequency Device in Cellulite, sponsored by Cutera Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.
The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.
At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 76 is above 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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Abdomen, flank or thigh treated with RF device
Device: Cutera Radio Frequency Device
Up to three treatments, one pass, dosage range of 15-60 kJ.
Also known as: Callisto, TruForm, TruSculpt
Change in Circumference (cm)
Time frame: Baseline and 6 months post final treatment
Subject Satisfaction
Time frame: Baseline and 6 months post final treatment
The Number of Participants With Adverse Events
At each visit (treatment and follow-up) or until resolution of AEs
Time frame: Up to 6 months after the last treatment
The study subjects were recruited in the medical clinic 01/01/09 through 01/13/10.
| Milestone | Radiofrequency (RF) Treatment |
|---|---|
| Started | 76 |
| Completed | 49 |
| Not completed | 27 |
| Withdrew: Lost to follow-up | 23 |
| Withdrew: Withdrawal by subject | 4 |
| Centimeters (cm) | Radiofrequency (RF) Treatment |
|---|---|
| Abdomen | -0.5 ± 2.2 |
| Thigh | 0.6 ± 4.7 |
| Flank | -1.4 ± 2.1 |
No measurements were reported for this outcome.
At each visit (treatment and follow-up) or until resolution of AEs
| Participants | Radiofrequency (RF) Treatment |
|---|---|
| Edema | 1 |
| Lumps | 3 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiofrequency (RF) Treatment | — | 0/49 (0%) | 3/49 (6.1%) |
| Event | Radiofrequency (RF) Treatment |
|---|---|
| LumpsInjury, poisoning and procedural complications | 3/49 |
| Age, Categorical(Participants) | Radiofrequency (RF) Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 76 |
| >=65 years | 0 |
| Age, Continuous(years) | Radiofrequency (RF) Treatment |
|---|---|
| Mean | 43 ± 8.5 |
| Sex: Female, Male(Participants) | Radiofrequency (RF) Treatment |
|---|---|
| Female | 69 |
| Male | 7 |
| Region of Enrollment(participants) | Radiofrequency (RF) Treatment |
|---|---|
| United States | 76 |
The record gives a start of Apr 2009, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2011, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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