Trial Outcomes & Findings for Non-Invasive Reduction of Abdominal Fat (NCT NCT01101997)

NCT ID: NCT01101997

Last Updated: 2020-12-21

Results Overview

Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

16 weeks

Results posted on

2020-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Zeltiq System Treatment Group The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Zeltiq System Treatment Group The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zeltiq System Treatment Group n=60 Participants The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
Age, Categorical <=18 years	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=60 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 9.3 • n=60 Participants
Sex: Female, Male Female	56 Participants n=60 Participants
Sex: Female, Male Male	4 Participants n=60 Participants
Region of Enrollment United States	60 participants n=60 Participants
Fitzpatrick Skin Type FST I-Always burns, never tans	5 Participants n=60 Participants
Fitzpatrick Skin Type FST II- Burns easily, tans poorlyy	22 Participants n=60 Participants
Fitzpatrick Skin Type FST III- Tans after initially burning	21 Participants n=60 Participants
Fitzpatrick Skin Type FST IV- Burns minimally, tans easily	10 Participants n=60 Participants
Fitzpatrick Skin Type FST V- Rarely burns, tans darkly easily	1 Participants n=60 Participants
Fitzpatrick Skin Type FST VI- Never burns	1 Participants n=60 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: The per protocol population are those subjects who were treated with the Zeltiq CoolSculping System and maintained weight as specified in the protocol.

Outcome measures

Outcome measures
Measure	Zeltiq System Treatment Group n=150 photos The per protocol population consists of all evaluable subjects treated with the Zeltiq System for the reduction of abdominal fat and whose weight change was within 5 pounds of baseline weight.
Proportion of Pre-treatment Images Correctly Identified	128 photos

SECONDARY outcome

Timeframe: 16 weeks

Population: All subjects who completed treatment with the Zeltiq System, independent of weight changes, were included in the analysis population.

Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm.

Outcome measures

Outcome measures
Measure	Zeltiq System Treatment Group n=58 Participants The per protocol population consists of all evaluable subjects treated with the Zeltiq System for the reduction of abdominal fat and whose weight change was within 5 pounds of baseline weight.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	-1.9 mm Standard Deviation 2.49

SECONDARY outcome

Timeframe: 16 weeks

Population: All evaluable subjects that completed the satisfaction questionnaire were included in the analysis.

Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.

Outcome measures

Outcome measures
Measure	Zeltiq System Treatment Group n=58 Participants The per protocol population consists of all evaluable subjects treated with the Zeltiq System for the reduction of abdominal fat and whose weight change was within 5 pounds of baseline weight.
Subject Satisfaction Procedure somewhat uncomfortable to very comfortab	88 percent of positive responses
Subject Satisfaction Visible change in contour of treated region	60 percent of positive responses
Subject Satisfaction At least a slight difference in fit of clothes	79 percent of positive responses
Subject Satisfaction Overall effect was about, or more than expected	50 percent of positive responses
Subject Satisfaction Overall satisfaction with the procedure	62 percent of positive responses
Subject Satisfaction Would repeat the procedure	62 percent of positive responses
Subject Satisfaction Would have the procedure on different body part	65 percent of positive responses
Subject Satisfaction Would recommend the procedure	67 percent of positive responses

Adverse Events

Zeltiq System Treatment Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zeltiq System Treatment Group n=60 participants at risk The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat.
Gastrointestinal disorders Nausea	3.3% 2/60 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
General disorders Pain	3.3% 2/60 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
Skin and subcutaneous tissue disorders Numbness	3.3% 2/60 • Number of events 2 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
General disorders Anxiety	1.7% 1/60 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
General disorders Vasovagal event	1.7% 1/60 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
General disorders Headache	1.7% 1/60 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.
Reproductive system and breast disorders Menorrhagia	1.7% 1/60 • Number of events 1 • Adverse event data were collected from the time of enrollment through the 16 week follow-up visit.

Additional Information

Kerrie Jiang, Executive Director Regulatory, Clinical and Medical Affairs

Zeltiq Aesthetics

Phone: (925) 621-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place