Trial Outcomes & Findings for Fat Layer Reduction in the Lateral Thighs Using CoolSculpting (NCT NCT02324816)

Last Updated: 2021-12-28

Results Overview

Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Enrollment through 12 week post-final treatment follow-up visit

Results posted on

2021-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lateral Thigh Treatment Group Non-invasive subcutaneous fat reduction in the lateral thighs treatment group The Zeltiq CoolSculpting System: CoolSculpting treatment.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fat Layer Reduction in the Lateral Thighs Using CoolSculpting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lateral Thigh Treatment Group n=19 Participants Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.0 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants
Race/Ethnicity, Customized Others	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Body Mass Index	26.5 kg//m^2^ n=5 Participants

PRIMARY outcome

Timeframe: Enrollment through 12 week post-final treatment follow-up visit

Outcome measures

Outcome measures
Measure	Lateral Thigh Treatment Group n=19 Participants Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
Safety of the Zeltiq CoolSculpting System in the Outer Thighs Device and/or procedure related AEs	8 events
Safety of the Zeltiq CoolSculpting System in the Outer Thighs UADEs reported	0 events

SECONDARY outcome

Timeframe: 12 weeks post-final treatment

Population: Photo pairs for 19 subjects were reviewed by blinded reviewers.

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. Success is defined as at least 70% correct identification of pre-treatment images by 2 out of 3 reviewers.

Outcome measures

Outcome measures
Measure	Lateral Thigh Treatment Group n=19 photo pairs Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
Percentage of Correctly Identified Pre-treatment Photographs	14 photo pairs

Adverse Events

Lateral Thigh Treatment Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lateral Thigh Treatment Group n=19 participants at risk Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System.
Skin and subcutaneous tissue disorders Prolonged swelling	21.1% 4/19 • Number of events 4 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Skin and subcutaneous tissue disorders Prolonged bruising	10.5% 2/19 • Number of events 2 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Skin and subcutaneous tissue disorders Erythema lasting > 2 weeks	10.5% 2/19 • Number of events 2 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Respiratory, thoracic and mediastinal disorders Cold with cough	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
General disorders 24 hour cold	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Surgical and medical procedures Rotator cuff pin adjustment	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Musculoskeletal and connective tissue disorders Tendonitis flare up	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Skin and subcutaneous tissue disorders Eczema	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.
Reproductive system and breast disorders Menopausal changes	5.3% 1/19 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week post-treatment 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 or the treatment.

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