N/A Completed N=35 Other

Multiple CoolSculpting Treatment Study

Body Fat Disorder

Source: ClinicalTrials.gov NCT01814007 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Dec 2020

Primary outcomePrimary: Evaluation of Liver- Related Tests Over Time — 62.12; 63.88; 63.74; 62.06 units per liter (U/L)

Summary

To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of Liver- Related Tests Over Time	62.12; 63.88; 63.74; 62.06; 19.66; 19.76	—
PRIMARY Evaluation of Liver-Related Tests Over Time	0.65; 0.53; 0.61; 0.58	—
PRIMARY Evaluation of Serum Lipid Values Over Time	186.54; 185.62; 188.38; 189.18; 76.97; 80.53	—
PRIMARY Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE	1; 0	—
SECONDARY Safety as Evaluated by the Number and Severity of All Reported Adverse Events.	1; 2	—
SECONDARY Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.	4; 0	—
SECONDARY Side Effects in Treatment Area	64; 31; 7; 1; 0; 54	—

Eligibility Criteria

Inclusion Criteria

Male or female subjects > 18 years of age.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
Lower Abdomen - One 60 minute cycle with CoolMax,
Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject agrees to not making any major changes in their diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.

Exclusion Criteria

Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
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 a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject has a history of hernia in the area(s) to be treated.
Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
Subject is lactating or has been lactating during the past 3 months.
Subject is unable or unwilling to comply with the study requirements, such as blood draw.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Subject has a history of lipodosis or other confounding metabolic diseases.
Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
Patient has a history of diabetes.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01814007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.