Trial Outcomes & Findings for Feasibility Study of a Belt Applicator (NCT NCT01767142)

Last Updated: 2020-10-26

Results Overview

For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Baseline to 16 weeks post-final treatment

Results posted on

2020-10-26

Participant Flow

Subjects with clearly visible fat in the treatment area (outer thigh) were recruited from two clinical research sites.

Screening of all subjects was completed to ensure each subject met all inclusion criteria and none of the exclusion criteria. A brief medical history and exam was performed at the screening visit. All female subjects of child bearing potential were given a pregnancy test.

Unit of analysis: Thighs

Participant milestones

Participant milestones
Measure	Lateral Thigh Treatment Group Treatment with the CoolSculpting System and a modified belt applicator will be performed. Non-invasive cooling is applied to one outer thigh with a protocol-defined cooling rate and duration of 120 minutes. Only one cooling cycle will be performed per subject.
Overall Study STARTED	40 40
Overall Study COMPLETED	37 37
Overall Study NOT COMPLETED	3 3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lateral Thigh Treatment Group Treatment with the CoolSculpting System and a modified belt applicator will be performed. Non-invasive cooling is applied to one outer thigh with a protocol-defined cooling rate and duration of 120 minutes. Only one cooling cycle will be performed per subject.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Feasibility Study of a Belt Applicator

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fat Reduction of the Lateral Thigh n=40 Participants Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. Treatment will be applied to one (1) outer thigh. The Zeltiq System with Modified Belt Applicator: 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	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	31 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Not specified	1 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants
Body Mass Index	25.3 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks post-final treatment

Population: The per-protocol population included all treated subjects who completed all follow-up visits and who maintained their body weight as directed by the study protocol. Six (6) subjects out of the 37 who completed the study, were excluded from the ultrasound measurement analysis because they had weight change greater than 5 pounds.

Outcome measures

Outcome measures
Measure	Fat Reduction of the Lateral Thigh n=31 Participants Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh	-0.25 cm Standard Deviation 0.23

PRIMARY outcome

Timeframe: Study enrollment through 16 weeks post-treatment

Population: The as-treated (safety) analysis population consists of all subjects treated in the study wherein a safety evaluation was completed. Three (3) subjects were lost to follow-up.

The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure.

Outcome measures

Outcome measures
Measure	Fat Reduction of the Lateral Thigh n=37 Participants Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Safety of the Zeltiq System and Procedure	1 Device/procedure-related AE

SECONDARY outcome

Timeframe: Baseline and 16 weeks post-final treatment

Population: Excluded from analysis are 6 subjects who did not maintain weight within protocol requirements and 3 subjects lost to follow-up.

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 (pre-treatment) photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.

Outcome measures

Outcome measures
Measure	Fat Reduction of the Lateral Thigh n=93 Photos Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Percent of Correct Identification of Pre-treatment Photos	78 Photos

SECONDARY outcome

Timeframe: 16 weeks post-treatment

Population: Of the forty enrolled subjects, three (3) were lost to follow-up and satisfaction questionnaires were not obtained.

Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. The questionnaire was composed of 5-point Likert scale questions, as well as free text responses. Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable responses.

Outcome measures

Outcome measures
Measure	Fat Reduction of the Lateral Thigh n=37 Participants Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Percentage of Participants With Satisfaction on Questionnaire Questions Procedure very to somewhat comfortable	75.7 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Very visible to somewhat visible fat reduction	86.5 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Positive overall effect	70.3 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Very to somewhat satisfied with procedure	86.5 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Somewhat to very different fit of clothing	51.4 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Very likely to somewhat likely to have another tx	97.3 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Very to somewhat likely to retreat the same area	62.2 Percent of subjects expressing satis fac
Percentage of Participants With Satisfaction on Questionnaire Questions Would recommend CoolSculpting to a friend	89.19 Percent of subjects expressing satis fac

Adverse Events

Fat Reduction of the Lateral Thigh

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fat Reduction of the Lateral Thigh n=40 participants at risk Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Infections and infestations Seasonal cold symptoms	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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 Injured hip	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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 Runny and stuffy nose	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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.
Infections and infestations Flu symptoms	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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.
Infections and infestations Ear pain and sore throat	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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 Pain/discomfort	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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 Numbness in treatment area	2.5% 1/40 • Number of events 1 • Adverse event data were collected from enrollment until the 16-week follow-up visit. The following definition was described in the study protocol: Adverse events (AE) will be assessed continuously throughout the study. 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