search
Back to results

Bilateral; Flank Study With Crown Cooling Insert (CCI)

Primary Purpose

Body Fat Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The ZELTIQ CoolSculpting System
Sponsored by
Zeltiq Aesthetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Fat Disorder

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female subjects > 22 years of age and < 65 years of age.
  • Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
  • No weight change exceeding 5% of body weight 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%) by not making any major changes in their diet or exercise routine during the course of the study.
  • Subject has read and signed the study 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 has a history of hernia in the areas to be treated.
  • 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.

Sites / Locations

  • Laser and Skin Surgery of Northern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study Participants

Arm Description

This is a split body study in which all subjects will receive bilateral flank treatment with CoolSculpting. The investigator will determine one flank for treatment using the CoolCore applicator without an accessory for a duration of 60 minutes at a protocol-defined temperature. The contralateral flank will be treated with the standard CoolCore Applicator using an applicator accessory, the Crown Cooling Insert (CCI) at a protocol-defined temperature for a duration of up to 45 minutes. All enrolled subjects receive identical treatments; the investigator will use alternate subject numbers to balance which flank to treat with and without the CoolCore applicator accessory, such that all even subject numbers will receive treatment using the Standard CoolCore on the right flank and odd subject numbers will receive the same treatment on the left flank.

Outcomes

Primary Outcome Measures

Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent 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 will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.

Secondary Outcome Measures

Subject Satisfaction
Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.

Full Information

First Posted
September 16, 2015
Last Updated
October 1, 2020
Sponsor
Zeltiq Aesthetics
search

1. Study Identification

Unique Protocol Identification Number
NCT02554760
Brief Title
Bilateral; Flank Study With Crown Cooling Insert
Acronym
CCI
Official Title
CoolSculpting the Flank Using an Applicator With a Crown Cooling Insert
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
December 17, 2015 (Actual)
Study Completion Date
December 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.
Detailed Description
This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Experimental
Arm Description
This is a split body study in which all subjects will receive bilateral flank treatment with CoolSculpting. The investigator will determine one flank for treatment using the CoolCore applicator without an accessory for a duration of 60 minutes at a protocol-defined temperature. The contralateral flank will be treated with the standard CoolCore Applicator using an applicator accessory, the Crown Cooling Insert (CCI) at a protocol-defined temperature for a duration of up to 45 minutes. All enrolled subjects receive identical treatments; the investigator will use alternate subject numbers to balance which flank to treat with and without the CoolCore applicator accessory, such that all even subject numbers will receive treatment using the Standard CoolCore on the right flank and odd subject numbers will receive the same treatment on the left flank.
Intervention Type
Device
Intervention Name(s)
The ZELTIQ CoolSculpting System
Intervention Description
The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.
Primary Outcome Measure Information:
Title
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent 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 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 will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Time Frame
12 weeks post-treatment
Title
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
Description
The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.
Time Frame
Enrollment through the 12 week post-treatment follow-up visit
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.
Time Frame
12 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects > 22 years of age and < 65 years of age. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment. No weight change exceeding 5% of body weight 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%) by not making any major changes in their diet or exercise routine during the course of the study. Subject has read and signed the study 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 has a history of hernia in the areas to be treated. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Kilmer, MD
Organizational Affiliation
Laser and Skin Surgery Center of Northern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser and Skin Surgery of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27327898
Citation
Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
Results Reference
result

Learn more about this trial

Bilateral; Flank Study With Crown Cooling Insert

We'll reach out to this number within 24 hrs