Trial Outcomes & Findings for CoolSculpting of the Distal Thigh Study (NCT NCT02335749)

Last Updated: 2021-12-01

Results Overview

The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Study enrollment through 12-week final follow-up visit, approximately 15 weeks

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment With Small Area Applicator Each enrolled subject was treated on a single thigh, in the distal region. The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CoolSculpting of the Distal Thigh Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Small Area Applicator n=40 Participants Each enrolled subject was treated on a single thigh, in the distal region. The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.6 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	28 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Body Mass Index	25.4 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Study enrollment through 12-week final follow-up visit, approximately 15 weeks

Population: All subjects treated with the CoolSculpting System and the Small Area Applicator were assessed for device- or procedure-lated adverse events.

Outcome measures

Outcome measures
Measure	Treatment With Small Area Applicator n=40 Participants Each enrolled subject was treated on a single thigh, in the distal region. The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Rate of Device- or Procedure-related Adverse Events	1 device-or procedure-related AEs

PRIMARY outcome

Timeframe: 12 weeks post final treatment

Population: Baseline and 12-week post-treatment photos were not reviewed by an independent panel of physicians due to inconsistencies of site photographic practices.

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. 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. Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted.

Outcome measures

Outcome data not reported

Adverse Events

Treatment With Small Area Applicator

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment With Small Area Applicator n=40 participants at risk Each enrolled subject was treated on a single thigh, in the distal region. The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Infections and infestations Throat infection	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.
General disorders Shingles	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.
General disorders Knee injury	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.
Skin and subcutaneous tissue disorders Erythema	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.
Skin and subcutaneous tissue disorders Bruise	2.5% 1/40 • Number of events 1 • Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.

Additional Information

Kerrie Jiang, Director Clinical Affairs

Zeltiq Aesthetics

Phone: 925-621-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place