Trial Outcomes & Findings for Pilot Study on The Flanks of Asian Patients (NCT NCT01623037)

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 and 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 70% correct identification of pre-treatment images.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 12 weeks post-final treatment

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	CoolSculpting Treatment Group The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study on The Flanks of Asian Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting Treatment Group n=15 Participants The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.1 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Hong Kong	15 participants n=5 Participants
BMI	22.8 kg//m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks post-final treatment

Population: All subjects in the analysis group were treated on each flank with CoolSculpting. Each subject had pre-treatment and post-treatment images taken.

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 and 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 70% correct identification of pre-treatment images.

Outcome measures

Outcome measures
Measure	CoolSculpting Treatment Group n=45 photos The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	Operator Feedback on CoolCurve + Applicator The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
Proportion of Pre-treatment Images Correctly Identified	32 photos	—

PRIMARY outcome

Timeframe: Enrollment through 12 weeks post-final treatment

Population: All subjects treated with the CoolSculpting device and CoolCurve+ applicator were included in the population.

The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.

Outcome measures

Outcome measures
Measure	CoolSculpting Treatment Group n=15 Participants The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	Operator Feedback on CoolCurve + Applicator The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
Safety of the CoolSculpting and the CoolCurve+ Applicator	0 device or procedure-related AE's	—

SECONDARY outcome

Timeframe: 12 weeks post final treatment

Population: All subjects completing the satisfaction questionnaire are included in the analysis population. Subject responses deemed inconclusive or not answered were excluded from the satisfactions counts.

Subject satisfaction as assessed by questionnaire administered at 12-weeks post-treatment will be tabulated. The questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied nor satisfied; 4) somewhat satisfied; 5) very satisfied.

Outcome measures

Outcome measures
Measure	CoolSculpting Treatment Group n=15 Participants The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	Operator Feedback on CoolCurve + Applicator The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
Subject Satisfaction With the Procedure Procedure comfortable to very comfortable	13 Participants	—
Subject Satisfaction With the Procedure Somewhat to very visible fat reduction	6 Participants	—
Subject Satisfaction With the Procedure Overall treatment effect about or more than expect	5 Participants	—
Subject Satisfaction With the Procedure Would recommend to a friend	4 Participants	—

SECONDARY outcome

Timeframe: Pre-treatment and 12 weeks post-final treatment

Population: Subjects included in the analysis population received CoolSculpting on both flanks and that had evaluable caliper measurements obtained pre-treatment and at 12 week post treatment.

Caliper measurements will be obtained prior to treatment and at the 12-week follow-up visit to assess for changes to the fat layers in the flanks. After the treatment area is identified and marked, the thickness of fat layer will be measured using a caliper at the middle of the fat bulge. For each treatment area, three (3) measurements will be taken and recorded. The average of the three measurements will be calculated. The location of where measurements were taken will be recorded on a transparency sheet along with reference points using the subject's body landmarks (such as a mole, skin pigmentation). This transparency will be used at post treatment visit to locate the measurement sites. Results will be reported in millimeters of fat layer.

Outcome measures

Outcome measures
Measure	CoolSculpting Treatment Group n=29 Treatment areas The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	Operator Feedback on CoolCurve + Applicator The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
Change in the Fat Layer Thickness	-1.4 millimeters of fat Standard Deviation 1.7	—

SECONDARY outcome

Timeframe: Pre-treatment/treatment day

Population: The operators using the device and applicators in the study participated in, or provided treatment using the Cool Curve and the CoolCurve+ applicator.

Operator performing or assisting with study procedure will complete two questionnaire at the treatment visit regarding the fit of two applicators: 1) CoolCurve+ and 2) CoolCurve The questionnaire consists of four multiple choice questions, each having a 5-point scale, with '5' representing the best and '1' the worst.

Outcome measures

Outcome measures
Measure	CoolSculpting Treatment Group n=15 Participants The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	Operator Feedback on CoolCurve + Applicator n=15 Participants The operator assessed the fit and tissue draw into each of 2 applicators. The assessment was done using a multiple choice questionnaire for each applicator type.
Operator Feedback	3.20 score on a scale	4.47 score on a scale

Adverse Events

CoolSculpting Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kerrie Jiang, Executive Director Regulaory, 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