Trial Outcomes & Findings for Non-Invasive Cooling of Fat Cells (NCT NCT00762437)
NCT ID: NCT00762437
Last Updated: 2025-05-25
Results Overview
Investigator assessment to document any visible improvement in the treatment area.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
4 months
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
All Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
All Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Missed final study visit
|
11
|
|
Overall Study
No treatment (unable to attach sleeve to participant)
|
1
|
Baseline Characteristics
Non-Invasive Cooling of Fat Cells
Baseline characteristics by cohort
| Measure |
All Participants
n=175 Participants
Zeltiq Dermal Cooling Device: Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Age, Continuous
|
44.9 Years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Participants with evaluable data for each body site were included in this analysis.
Investigator assessment to document any visible improvement in the treatment area.
Outcome measures
| Measure |
Back Fat
n=69 Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
Love Handles
n=58 Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|---|
|
Percentage of Participants With Visible Improvement in Treated Area
|
65.2 percentage of participants
Interval 52.8 to 76.3
|
82.8 percentage of participants
Interval 70.6 to 91.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants with evaluable data for each body site were included in this analysis. The row titled "Percentage of participants 'Both Satisfied and Dissatisfied' on Subject Satisfaction Questionnaire" was not applicable to the Love Handle treatment area, so no data were collected.
Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire.
Outcome measures
| Measure |
Back Fat
n=74 Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
Love Handles
n=65 Participants
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|---|
|
Participant Satisfaction
Percentage of participants with "overall satisfaction" on Subject Satisfaction Questionnaire
|
51.4 percentage of participants
Interval 39.4 to 63.1
|
58.5 percentage of participants
Interval 45.6 to 70.6
|
|
Participant Satisfaction
Percentage of participants "Dissatisfied" on Subject Satisfaction Questionnaire
|
8.1 percentage of participants
Interval 3.0 to 16.8
|
6.2 percentage of participants
Interval 1.7 to 15.0
|
|
Participant Satisfaction
Percentage of participants "Neither Satisfied nor Dissatisfied"on Subject Satisfaction Questionnaire
|
32.4 percentage of participants
Interval 22.0 to 44.3
|
35.4 percentage of participants
Interval 23.9 to 48.2
|
|
Participant Satisfaction
Percentage of participants "Both Satisfied and Dissatisfied" on Subject Satisfaction Questionnaire
|
8.1 percentage of participants
Interval 3.0 to 16.8
|
—
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=175 participants at risk
Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration.
|
|---|---|
|
Cardiac disorders
Syncope
|
1.1%
2/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Vascular disorders
Fainting
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
General disorders
Chest Pain
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Cardiac disorders
Elevated Heart Rate
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
General disorders
Vasovagal event
|
1.1%
2/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Hepatobiliary disorders
Gallbladder attack
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
General disorders
Toe Pain
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Nervous system disorders
Tingling
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
General disorders
Rib Soreness
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
|
General disorders
|
0.57%
1/175 • All-cause mortality and adverse event tables include events reported from first treatment through study completion, an average of 6 months.
|
Additional Information
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