DST: CoolSculpting of the Distal Thigh Study

• Sponsor: Zeltiq Aesthetics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02335749
• Collaborator: (none)
• Enrollment: 40
• Locations: 4
• Arm: 1
• Actual Duration (Months): 10.7
• Patients Per Site: 10
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

Condition or Disease	Intervention/Treatment	Phase
Body Fat Disorder	Device: The ZELTIQ System	N/A

Detailed Description

This study will investigate the use of a Small Area Applicator with the CoolSculpting device for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and effectiveness of treatments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: CoolSculpting Treatment of the Distal Thigh
• Actual Study Start Date: Dec 17, 2014
• Actual Primary Completion Date: Nov 9, 2015
• Actual Study Completion Date: Nov 9, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with Small Area Applicator Each enrolled subject was treated on a single thigh, in the distal region.	Device: The ZELTIQ System; The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.; Other Names: CoolSculpting System

Outcome Measures

Primary Outcome Measures

1. Rate of Device- or Procedure-related Adverse Events [Study enrollment through 12-week final follow-up visit, approximately 15 weeks]

   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.

2. Proportion of Correctly Identified Photos by Blinded Reviewers [12 weeks post final treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female subjects > 22 years of age and < 65 years of age.

• Subject has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment.

• Subject has not had weight change exceeding 10 pounds in the preceding month.

• Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.

• Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.

• Subject has read and signed a written informed consent form.

Exclusion Criteria:

• Subject has had a surgical procedure(s) in the area of intended treatment.

• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.

• Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.

• Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.

• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.

• Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.

• Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.

• Subject is taking or has taken diet pills or supplements within the past month.

• Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).

• Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system

• Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).

• Subject is lactating or has been lactating in the past 6 months.

• Subject is unable or unwilling to comply with the study requirements.

• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.

• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bowes Dermatology Group	Miami	Florida	United States	33133
2	SkinCare Physicians of Chestnut Hill	Chestnut Hill	Massachusetts	United States	02467
3	Laser & Skin Surgery Center of New York	New York	New York	United States	10016
4	Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Zeltiq Aesthetics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeltiq Aesthetics
• ClinicalTrials.gov Identifier: NCT02335749
• Other Study ID Numbers: ZA14-004
• First Posted: Jan 12, 2015
• Last Update Posted: Dec 1, 2021
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Lipid Metabolism Disorders

Study Results

Participant Flow

Arm/Group Title	Treatment With Small Area Applicator
Arm/Group Description	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.
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment With Small Area Applicator
Arm/Group Description	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 Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	44.6
Sex: Female, Male (Count of Participants)
Female	40 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 5%
African American	1 2.5%
Hispanic	9 22.5%
Caucasian	28 70%
Region of Enrollment (participants) [Number]
United States	40 100%
Body Mass Index (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	25.4

Outcome Measures

1. Primary Outcome

Title	Rate of Device- or Procedure-related Adverse Events
Description	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.
Time Frame	Study enrollment through 12-week final follow-up visit, approximately 15 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment With Small Area Applicator
Arm/Group Description	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.
Measure Participants	40
Number [device-or procedure-related AEs]	1

2. Primary Outcome

Title	Proportion of Correctly Identified Photos by Blinded Reviewers
Description	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.
Time Frame	12 weeks post final treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment With Small Area Applicator
Arm/Group Description	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.
Measure Participants	0
Measure photo pairs	0

Adverse Events

Time Frame	Adverse event data were collected from the time of subject enrollment through the final follow-up visit, ap period of approximately 15 weeks.
Arm/Group Title	Treatment With Small Area Applicator
Arm/Group Description	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.
All Cause Mortality
	Treatment With Small Area Applicator
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Treatment With Small Area Applicator
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Treatment With Small Area Applicator
	Affected / at Risk (%)	# Events
Total	5/40 (12.5%)
General disorders
Shingles	1/40 (2.5%)	1
Knee injury	1/40 (2.5%)	1
Infections and infestations
Throat infection	1/40 (2.5%)	1
Skin and subcutaneous tissue disorders
Erythema	1/40 (2.5%)	1
Bruise	1/40 (2.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.