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Feasibility Study of a Belt Applicator

Primary Purpose

Body Fat Disorder

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

About this trial

This is an interventional treatment trial for Body Fat Disorder focused on measuring Lipolysis, Cryolipolysis, Fat Reduction

Eligibility Criteria

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

Inclusion Criteria

  • Male or female subjects > 18 years of age and < 65 years of age.
  • Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s).
  • 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 pounds) by not making any major changes in his/her diet or lifestyle 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 6 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 in the next 8 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.

Sites / Locations

  • Marina Plastic Surgery
  • Innovation Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Outer Thigh CoolSculpting Treatment

Arm Description

Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.

Outcomes

Primary Outcome Measures

Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh
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.
Safety of the Zeltiq System and Procedure
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.

Secondary Outcome Measures

Percent of Correct Identification of Pre-treatment Photos
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.
Percentage of Participants With Satisfaction on Questionnaire Questions
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.

Full Information

First Posted
January 9, 2013
Last Updated
October 1, 2020
Sponsor
Zeltiq Aesthetics
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1. Study Identification

Unique Protocol Identification Number
NCT01767142
Brief Title
Feasibility Study of a Belt Applicator
Official Title
Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.
Detailed Description
The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a modified belt applicator for the reduction of fat on the outer thigh. This is an open label, interventional, non-randomized feasibility study.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Outer Thigh CoolSculpting Treatment
Arm Type
Experimental
Arm Description
Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.
Intervention Type
Device
Intervention Name(s)
The Zeltiq System with Modified Belt Applicator
Other Intervention Name(s)
Cryolipolysis
Intervention Description
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh
Description
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.
Time Frame
Baseline to 16 weeks post-final treatment
Title
Safety of the Zeltiq System and Procedure
Description
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.
Time Frame
Study enrollment through 16 weeks post-treatment
Secondary Outcome Measure Information:
Title
Percent of Correct Identification of Pre-treatment Photos
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 (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.
Time Frame
Baseline and 16 weeks post-final treatment
Title
Percentage of Participants With Satisfaction on Questionnaire Questions
Description
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.
Time Frame
16 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Male or female subjects > 18 years of age and < 65 years of age. Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s). 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 pounds) by not making any major changes in his/her diet or lifestyle 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 6 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 in the next 8 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bachelor, MD
Organizational Affiliation
Innovation Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marina Plastic Surgery
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Innovation Research Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4462597/
Description
Cryolipolysis Conformable-Surface Applicator for Nonsurgical Fat Reduction in Lateral Thighs

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Feasibility Study of a Belt Applicator

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