Body Fat Disorder
Conditions
Brief summary
Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
Interventions
DEVICEZeltiq CoolSculpting System alone
The CoolSculpting System will be used to perform the treatments in Cohort 3.
DEVICEElectromagnetic Muscle Stimulation alone
The EMS device(s) alone are used in Cohort 1.
DEVICEEMS followed by CoolSculping
Cohort 2 group will be treated with EMS followed by CoolSculpting
DEVICECoolSculpting followed by EMS
Cohort 4 will be treated first with CoolSculpting, followed by EMS.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects \> 22 years of age and ≤65 years of age. * Subject has not had weight change exceeding 5% of body weight in the preceding month. * Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study. * Subject agrees to refrain from any new abdominal training exercises during the course of the study. * BMI ≤ 30 kg/m\^2 as determined at screening. * Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus. * Cohort 4 only: Subject participated in protocol ZA18-003 in Cohort 3, and received the CoolSculpting treatment no more than 6 months prior. * Subject has read and signed a written informed consent form.
Exclusion criteria
* Subject has had a surgical procedure(s) in the area of intended treatment. * Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * Subject has had a non-invasive fat reduction, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months. * Subject has numbness, tingling or other altered sensation in the treatment area. * Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * Subject has not had an intrauterine contraceptive device inserted or removed within the past month. * Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria * Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising. * Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or latex. * Subject is taking or has taken diet pills or supplements within the past month. * Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * Subject has a metal implant or active implanted device such as a pacemaker, defibrillator, or drug delivery system. * Subject has been involved in any type of abdominal muscle training program within the previous 6 months. * Subject has pulmonary insufficiency. * Subject has a cardiac disorder. * Subject has a malignant tumor. * Subject has been diagnosed with epilepsy. * Subject currently has a fever. * Subject is pregnant or intending to become pregnant during the study period (in the next 9 months). * Subject is lactating or has been lactating in the past 6 months. * Subject is unable or unwilling to comply with the study requirements. * Subject is currently enrolled in a clinical study of any other investigational drug or device. * Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unanticipated Adverse Device Effects (UADE) | Enrollment through the final 12-week follow-up visit. | The number of UADEs occurring during the study will be tabulated. |
| Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent) | Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit. | Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of very much improved, much improved, improved, no change, worse, much worse, or very much worse, with very much improved representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved (Very Much Improved, Much Improved, and Improved). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pre-treatment and Post-treatment Abdominal Circumference | Baseline and final 12-week follow-up visit. | Abdominal circumference as measured by 3-Dimensional imaging prior to treatment (baseline) is compared to images collected at the final 12-week post-treatment follow-up visit. Measurements were captured at 3 points including the upper, middle and lower abdomen. All measurements were averaged per subject at the baseline and 12-week visit time points to obtain circumference values. Results for each cohort are shown in millimeters of circumference reduction. |
| Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement | Final post-treatment 12-week follow-up visit | Subjects completed a graded 7-point GAIS at 12-week post-final treatment follow-up. The scale consists of the following response options: 3 = Very much improved; 2 = Much improved; 1 = Improved; 0 = No change; -1 = Worse; -2 = Much worse; -3 = Very much worse. Results were tabulated across the three treatment cohorts. Results were calculated in the percentage of the subjects reporting improvement. |
Countries
United States
Participant flow
Pre-assignment details
A total of 50 participants enrolled into Cohorts 1, 2, and 3. One subject enrolled in Cohort 3, received the treatment and completed all follow-up visits per Cohort 3 before subsequently rolling over to, and receiving treatment planned for Cohort 4. No other subjects were enrolled in Cohort 4. Efficacy data for Cohort 4 was excluded from analysis to avoid the perception of enhancing study enrollment. Data from this participant's treatment in Cohort 3 was included in all endpoint analyses.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1-EMS Only Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used. | 20 |
| Cohort 2 - EMS Followed by CoolSculpting articipants were treated with EMS (4 sessions) followed by 1 CoolSculpting treatment (3-6 cooling cycles) | 20 |
| Cohort 3 - CoolSculpting Only Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles) | 10 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Cohort 3 - CoolSculpting Only | Cohort 1-EMS Only | Cohort 2 - EMS Followed by CoolSculpting |
|---|---|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 11 | 47.7 years STANDARD_DEVIATION 7.9 | 43.5 years STANDARD_DEVIATION 12.8 | 38.2 years STANDARD_DEVIATION 9.3 |
| Body Mass Index | 23.5 kg/m^2 STANDARD_DEVIATION 2.3 | 23.9 kg/m^2 STANDARD_DEVIATION 2.1 | 22.6 kg/m^2 STANDARD_DEVIATION 2.1 | 24.1 kg/m^2 STANDARD_DEVIATION 2.3 |
| Race/Ethnicity, Customized Am. Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 43 Participants | 8 Participants | 17 Participants | 18 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pac Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 50 Participants | 10 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 38 Participants | 8 Participants | 16 Participants | 14 Participants |
| Sex: Female, Male Male | 12 Participants | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 10 | 0 / 1 |
| other Total, other adverse events | 0 / 20 | 2 / 20 | 1 / 10 | 0 / 1 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 10 | 0 / 1 |
Outcome results
Primary
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of very much improved, much improved, improved, no change, worse, much worse, or very much worse, with very much improved representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved (Very Much Improved, Much Improved, and Improved).
Time frame: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.
Population: All enrolled participants in Cohort 1 were included in the efficacy analysis. Cohort 2 excluded 1 participant for weight outside of protocol requirements and 1 subject for lack of 12-week follow-up photos. Cohort 3 excluded 1 participant due to a surgical procedure in the treatment area. Cohort 4 excluded one participant previously enrolled and treated in Cohort 3 (allowed per protocol); participant included in Cohort 3 analysis only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1-EMS Only | Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent) | 16 Participants |
| Cohort 2 - EMS and CoolSculpting | Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent) | 16 Participants |
| Cohort 3 - CoolSculpting Only | Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent) | 8 Participants |
Primary
Number of Unanticipated Adverse Device Effects (UADE)
The number of UADEs occurring during the study will be tabulated.
Time frame: Enrollment through the final 12-week follow-up visit.
Population: All Participants who received at least one study treatment. Participants in all cohorts were evaluated for adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1-EMS Only | Number of Unanticipated Adverse Device Effects (UADE) | 0 events |
| Cohort 2 - EMS and CoolSculpting | Number of Unanticipated Adverse Device Effects (UADE) | 0 events |
| Cohort 3 - CoolSculpting Only | Number of Unanticipated Adverse Device Effects (UADE) | 0 events |
| Cohort 4 - CoolSculpting Followed by EMS | Number of Unanticipated Adverse Device Effects (UADE) | 0 events |
Secondary
Change in Pre-treatment and Post-treatment Abdominal Circumference
Abdominal circumference as measured by 3-Dimensional imaging prior to treatment (baseline) is compared to images collected at the final 12-week post-treatment follow-up visit. Measurements were captured at 3 points including the upper, middle and lower abdomen. All measurements were averaged per subject at the baseline and 12-week visit time points to obtain circumference values. Results for each cohort are shown in millimeters of circumference reduction.
Time frame: Baseline and final 12-week follow-up visit.
Population: There were no exclusions from efficacy analysis in Cohort 1. One (1) participant in Cohort 2 was excluded from the analysis due to weight outside requirements of the protocol; 1 participant from cohort 3 was excluded due to a surgical treatment; cohort 4 consisted of a single participant treated in cohort 3 and subsequently rolled over to cohort 4 after cohort 3 final follow-up was completed. Cohort 4 was therefore not analyzed for efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1-EMS Only | Change in Pre-treatment and Post-treatment Abdominal Circumference | -4 mm | Standard Deviation 16 |
| Cohort 2 - EMS and CoolSculpting | Change in Pre-treatment and Post-treatment Abdominal Circumference | -15 mm | Standard Deviation 11 |
| Cohort 3 - CoolSculpting Only | Change in Pre-treatment and Post-treatment Abdominal Circumference | -10 mm | Standard Deviation 18 |
Secondary
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement
Subjects completed a graded 7-point GAIS at 12-week post-final treatment follow-up. The scale consists of the following response options: 3 = Very much improved; 2 = Much improved; 1 = Improved; 0 = No change; -1 = Worse; -2 = Much worse; -3 = Very much worse. Results were tabulated across the three treatment cohorts. Results were calculated in the percentage of the subjects reporting improvement.
Time frame: Final post-treatment 12-week follow-up visit
Population: All enrolled subjects with a completed S-GAIS at post-treatment 12-week follow-up visit. Cohort 4 was not included in the tabulation as the single subject treated in this cohort had been previously treated in Cohort 3 (allowed per protocol). Results for the single subject treated in both Cohort 3 and Cohort 4 were tabulated with Cohort 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1-EMS Only | Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement | 70 percentage of participants |
| Cohort 2 - EMS and CoolSculpting | Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement | 89 percentage of participants |
| Cohort 3 - CoolSculpting Only | Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement | 100 percentage of participants |