Trial Outcomes & Findings for CoolSculpting System (NCT NCT04506307)
NCT ID: NCT04506307
Last Updated: 2025-03-10
Results Overview
Photographs of the treatment areas (torso) taken at baseline and 12-weeks after final treatment were assessed by blinded independent reviewers to determine if the CoolSculpting treatment had the effect of improvement in the reduction of fat. The reviewers were presented with 2 series of photographs the baseline and the post final treatment series, and asked to select the series representing the baseline photographs. The order in which the photographs were presented was randomized by participant. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. Success was defined as at least 70% correct identification of the baseline images.
COMPLETED
NA
35 participants
Week 12 post final treatment (18 weeks after first treatment)
2025-03-10
Participant Flow
Participant milestones
| Measure |
CoolSculpting of the Torso
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Received 1 Treatment
|
35
|
|
Overall Study
Received 2 Treatments
|
30
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CoolSculpting System
Baseline characteristics by cohort
| Measure |
CoolSculpting of the Torso
n=35 Participants
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
24 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 12 post final treatment (18 weeks after first treatment)Population: Per Protocol population consisted of participants who received 2 treatments and had a weight change of no more than 5% of total body weight at the time the 12-week assessments were performed compared to the weight obtained at the first treatment visit. In addition, participants with extensive tattoos in the treated area that could hinder the evaluation were excluded.
Photographs of the treatment areas (torso) taken at baseline and 12-weeks after final treatment were assessed by blinded independent reviewers to determine if the CoolSculpting treatment had the effect of improvement in the reduction of fat. The reviewers were presented with 2 series of photographs the baseline and the post final treatment series, and asked to select the series representing the baseline photographs. The order in which the photographs were presented was randomized by participant. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. Success was defined as at least 70% correct identification of the baseline images.
Outcome measures
| Measure |
CoolSculpting of the Torso
n=28 Participants
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel
|
75.0 % of images identified correctly
Interval 55.1 to 89.3
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SECONDARY outcome
Timeframe: From first treatment up to Week 12 post final treatment (18 weeks after first treatment)Population: The Safety Population consisted of all enrolled participants who received at least 1 treatment.
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Outcome measures
| Measure |
CoolSculpting of the Torso
n=35 Participants
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
Device and/or Procedure Related AEs
|
11 Participants
|
|
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
SADEs
|
0 Participants
|
Adverse Events
CoolSculpting of the Torso
Serious adverse events
| Measure |
CoolSculpting of the Torso
n=35 participants at risk
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Injury, poisoning and procedural complications
Back injury
|
2.9%
1/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
Other adverse events
| Measure |
CoolSculpting of the Torso
n=35 participants at risk
Participants were to receive 2 CoolSculpting treatments of the torso (abdomen, flanks, bra fat, and/or back fat) performed at 6 weeks apart.
|
|---|---|
|
Infections and infestations
COVID-19
|
5.7%
2/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.7%
2/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
General disorders
Vasovagal event
|
11.4%
4/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous induration
|
5.7%
2/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
2/35 • Baseline up to 12 weeks post final treatment (up to 18 weeks)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
Additional Information
Sally Hallas, RN, Director Clinical Development - Body Contouring
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER