Trial Outcomes & Findings for Non-Invasive Reduction of Fat in the Inner Thighs (NCT NCT01517659)

Last Updated: 2021-12-03

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 at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

16 weeks post-treatment

Results posted on

2021-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Fat Reduction in Inner Thighs The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Invasive Reduction of Fat in the Inner Thighs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fat Reduction in Inner Thighs n=45 Participants The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.1 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Others	1 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks post-treatment

Population: The per protocol population included all subjects who completed follow-up visits and maintained weight within protocol-defined criteria. Pairs of subject photos (pre-treatment + post-treatment) were presented to blinded reviewers. Reviewers were blinded to time points of photos and the order of photo presentations was randomized.

Outcome measures

Outcome measures
Measure	Fat Reduction in Inner Thighs n=42 photo pairs The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Percentage of Pre-Treatment Images Correctly Identified by Reviewers	90.5 percentage of correct identifications Interval 84.4 to 94.7

PRIMARY outcome

Timeframe: Enrollment through 16 weeks post-treatment

Population: All subjects treated with CoolSculpting were included in the analysis group.

The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.

Outcome measures

Outcome measures
Measure	Fat Reduction in Inner Thighs n=45 Participants The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Safety of the CoolSculpting Device and/or Procedure	14 device-or procedure-related AEs

SECONDARY outcome

Timeframe: 16 weeks post-treatment

Population: The analysis population included all subject responses collected at the 16 week follow-up visit.

Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Fat Reduction in Inner Thighs n=45 Participants The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Subject Satisfaction Would recommend CoolSculpting to friend	40 Participants
Subject Satisfaction Very to somewhat satisfied w/ procedure and result	42 Participants
Subject Satisfaction Very visible to somewhat visible fat reduction	38 Participants
Subject Satisfaction Positive overall effect	36 Participants
Subject Satisfaction Very likely to somewhat likely to have another tx	41 Participants

SECONDARY outcome

Timeframe: 16 week-post-treatment

Population: Population includes all subjects with completed ultrasound images and who maintained weight within the protocol-defined weight requirement.

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 untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control region. Results indicate the fat layer reduction in millimeters.

Outcome measures

Outcome measures
Measure	Fat Reduction in Inner Thighs n=76 treated and control sites The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound	-2.8 mm Standard Deviation 2.29

Adverse Events

Fat Reduction in Inner Thighs

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fat Reduction in Inner Thighs n=45 participants at risk The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Endocrine disorders Adrenal gland mass	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Musculoskeletal and connective tissue disorders Herniated spinal disc	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.

Other adverse events

Other adverse events
Measure	Fat Reduction in Inner Thighs n=45 participants at risk The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Skin and subcutaneous tissue disorders Numbness, persistent numbness	26.7% 12/45 • Number of events 12 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Musculoskeletal and connective tissue disorders Left shoulder injury; capsular tear	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Skin and subcutaneous tissue disorders Discoloration on soles of feet	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Infections and infestations Influenza	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Nervous system disorders Seizure	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Skin and subcutaneous tissue disorders Indentation	2.2% 1/45 • Number of events 1 • Adverse event data was collected from enrollment through the 16 week follow-up visit. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.

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